Agenda - Health Sciences Authority · Any warnings and precautions must correspond between clinical...

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HSA industry workshop clinical evaluation medical devices © 2012 WMDO

HSA BRIEFING & WORKSHOP ON CLINICAL

DEVELOPMENT OF MEDICAL DEVICES

Danielle Giroud


Agenda

Clinical Evaluation methods and

definitions

Clinical evaluation through existing data

Clinical evaluation through prospective

clinical investigation

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Agenda

Clinical investigation design

Clinical investigation conduct

Post market surveillance


CLINICAL EVALUATION

METHODS AND DEFINITIONS

Part 1

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Medical device lifecycle

Changes to the device or new design

IDEA TO PRODUCT CONCEPTION

Proof Of Concept & Risk Assessment

. .

.

. Design Engineering

Regulatory Strategy

PRELIMINARY PRODUCT FREEZE

Manufacturing

Quality Assurance

DESIGN VERIFICATION

PRE-CLINICAL VALIDATION

Toxicology Sterility

Biocompatibility

SAFETY/ PERFORMANCE EFFECTIVENESS VALIDATION

First in Man

PRODUCT FREEZE DESIGN VALIDATION

FINAL CLINICAL EVALUATION

MARKET RELEASE

POST MARKET SURVEILLANCE

Reimbursement Strategy

Pivotal Trial

MASS PRODUCTION


Clinical Evaluation methods

Clinical Evaluation is the assessment and analysis of

clinical data pertaining to a medical device, to verify

clinical performance and safety of the device, when used

as intended by the manufacturer.

Demonstrating safety and performance is part of the

essential principles applicable to all devices.

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Clinical Evaluation methods

Clinical evaluation through : 1. Critical review of existing data - ALWAYS

2. Prospective clinical investigation – when needed


Defining the claims 3

Clinical Performance and safety

Clinical performance, effectiveness and safety

Performance vs. Effectiveness

http://upload.wikimedia.org/wikipedia/commons/4/48/Flag_of_Singapore.svg

http://upload.wikimedia.org/wikipedia/en/a/a4/Flag_of_the_United_States.svg

http://upload.wikimedia.org/wikipedia/en/9/9e/Flag_of_Japan.svg

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Defining the claims 3

Clinical Performance and safety

Clinical performance, effectiveness and safety

Performance vs. Effectiveness

Clinical Performance (ISO 14155:2011) behaviour of a

medical device or response of the subject(s) to that medical

device in relation to its intended use, when correctly applied

to appropriate subject(s)


Performance vs Effectiveness

(WHO)

‘A device is clinically effective when it produces the

effect intended by the manufacturer relative to the

medical condition.’ For example, if a device is intended for pain relief, one expects the device to actually

relieve pain and would also expect the manufacturer to possess objective, scientific

evidence, such as clinical test results, that the device does in fact relieve pain.

http://upload.wikimedia.org/wikipedia/commons/4/48/Flag_of_Singapore.svg

http://upload.wikimedia.org/wikipedia/en/a/a4/Flag_of_the_United_States.svg

http://upload.wikimedia.org/wikipedia/en/9/9e/Flag_of_Japan.svg

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(WHO)

‘Clinical effectiveness is a good indicator of device

performance. Performance, however, may include

technical functions in addition to clinical effectiveness.’ For example, an alarm feature may not directly contribute to clinical effectiveness but

would serve other useful purposes.

‘It is easier to measure objectively and quantify

performance than clinical effectiveness.’



(WHO)

‘Performance is closely linked to safety.’ For example, an infusion pump that does not perform properly and allows wrong flow

rate can induce serious clinical safety problems to the patient. A patient monitor that

does not perform well could pose serious clinical safety problems to the patient.

‘The safety and performance of medical devices are

normally considered closely together.’

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CLINICAL EVALUATION

THROUGH EXISTING DATA

Part 2


RA report Critical

literature review

Design dossier

Pre-clinical evaluation

report

Risk management: a continuous

process

Clinical Investigation

data

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Risk Analysis and Management Standards

Risk management


Risk Analysis Definitions

Risk management

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Risk management

ISO 14155:2011 risk evaluation ‘risks associated with the investigational device shall be

estimated in accordance with ISO 14971 prior to conducting

a clinical investigation’

‘The risk analysis shall include or refer to an objective

review of published and available unpublished medical and

scientific data’


Risk management

ISO 14155:2011 risk evaluation ‘a summary of the RA, including an identification of residual

risks shall be included in the investigator brochure’

‘residual risks from RA and those associated with the

procedures imposed by a clinical investigation plan cannot

outweigh the benefits’

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Risk management

ISO 14155:2011 risk evaluation ‘risk analysis shall be used as a basis for identifying

anticipated adverse device effects, characterized by their

nature, incidence, severity and outcome’


Risk management

Common pittfalls with the risk analysis: • Not existing

• Incomplete Technical only – no clinical risks considered

Clinical condition of patient not taken into account i.e. sick patients how well can

they tolerate the new treatment

• No medical/clinical judgement

• Only briefly referenced in the investigator brochure but conclusion

on residual risks is missing.

• Safety claims are not clearly identified.

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Risk management

Clear identification of residual risks • Form the basis for safety claims

• Form the basis of safety objectives of clinical evaluation

Example 1: a bioresorbable implant presents no toxic effects during pre-clinical

validation – but no experience exists on a long term basis in humans. This may

be one of the objectives of a clinical investigation.

Example 2: a bioresorbably implant of a known material used in a different part

of the body – different intended use - . In the RA we may assume no toxic

effects, but this should be an objective of the literature search


A. The graphic

Clinical evaluation

Tree steps

1. Risk Assessment

a) Intended use

b) Safety claims or concerns

2. Design freeze

a) Technical characteristics

b) Performance claims

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A. The graphic

Clinical evaluation

Tree steps

1. Risk Assessment

a) Intended use

b) Safety claims or concerns

2. Design freeze

a) Technical characteristics

b) Performance claims

Step 1: Identify clincial data

Step 2: Appraisal of data sets

Step 3: Analysis and conclusion


Starting point

The safety points from the risk analysis

The performance claims for a defined medical device design

Within a given intended use

Multiple intended use?

Multiple clinical evaluations

Critical review of existing data: check the methodology

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Starting with

Objectives of a clinical evaluation through existing data

Directly in relation with the proof of compliance to the essential principles

Includes safety data points defined by the risk analysis

Contains detailed performance criteria for the device corresponding to other parts of the technical file.

Questions?:

1. do pre-clinical data indicate safety concerns that require a prospective clinical investigation?

2. Are there more cl aims in the technical file than covered in the evaluation?

3. Are all claims from the risk analysis covered by data from the literature or pre-clinical data? Did we find additional safety data?

4. Are there different performance claims found in the literature?



Starting with

Formulate the objectives of a clinical evaluation through existing data

Identify clinical data

Questions ?

1. Are data statistically meaningful to support claims?

2. Are there limitations in confirming safety in animals?

3. Have all data been taken into account? Is the search for data reproducible?

4. Is there a plausible justification for dropping certain literature resources?


Small sample sizes

Products subject to warning letters

Unpublished data

Vigilance data bases

No valid conclusions

Does this apply to us?

Including negative results

Learn from the past

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Starting with


Identify clinical data from

Evaluate

Suitability and quality of the data sources found

Are data meaningful to reach the objective of the clinical evaluation?

Are all applicable data sources used?

Is the strategy for handling duplicate data across multiple publications addressed?

Are data sources appropriate to define the design of a clinical investigation plan?



Starting with



Evaluate

Analyze

Apply objective thought process

Use quantifiable methods


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Starting with



Evaluate

Analyze

Conclude

Statistical strength of the data analyzed in relation to the objectives

Each safety point needs justification in the conclusion

Remaining risks cannot outweigh the benefits to the subjects

Possible risks and discomforts must be described in labeling

Any warnings and precautions must correspond between clinical evaluation report, risk analysis and labeling



Starting with



Evaluate

Analyze

Conclude

Safety conclusions need to include consideration of pre-clinical data on the device in question

Take into account additional requirements for specific standards or guidance documents applicable to the medical device in question

Demonstration of evidence for safety and performance ?

• If yes – conclude the report

• If no – conclude the report and define further data needed


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Data from equivalent devices

Critical review of existing data: Choice of comparator?

Clinical condition

Severity and stage of disease

Body site

Patient population

Same intended use

Compare Technical properties

Design

Specifications

Physiochemical properties

Energy intensity

Deployment methods

Critical performance requirements

Principles of operations

Conditions of use

Compare Biological properties Biocompatibility of materials in contact

with same body fluids/tissue


Clinical competence

Technical/procedural knowhow

Regulatory knowhow

Research methodology

Author free from any conflict of interest or

supported by independent review

Manufacturer

Critical review of existing data: expertise

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No

Yes

Yes

Sufficient data to demonstrate safety and performance?


(literature review)

Report ready for conformity assessment

Plan post market clinical follow up as appropriate

Additional safety or performance criteria

found?

Take additional findings in consideration in risk

analysis and design file

Critical review of existing data: in summary


No

No

Yes

Yes

Sufficient data to demonstrate safety and performance?


(literature review)

Report ready for conformity assessment

Plan post market clinical follow up as appropriate

Plan further actions

1. Additional literature

2. Prospective clinical investigation

Additional safety or performance criteria

found?

Take additional findings in consideration in risk

analysis and design file

Critical review of existing data: in summary

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CLINICAL INVESTIGATION

Part 3


A. The graphic

Available data

Justifies the design

Justifies the clinical investigation

Lack of data

Literature must be reviewed

Clinical Investigation:Pre-requisites

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Open non-randomized clinical investigation

Randomized

Single

Safety and performance validation

To confirm safety and effectiveness endpoints

Double

Used to eliminate the subjectivity of data. Difficult to set-up.

Type of study

Design of a clinical investigation

Blinded

Types of clinical investigations


Need to start with a

pilot population

Usually to confirm the

design of new device

Can help determine the follow

up time points for endpoints

Type of study

Pilot investigation



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Interim analysis

Problems found No problems found

Investigation goes on

Fix problems

Requires an amendment :may cause delays

Type of study

Pilot investigation


Type of clinical investigations

Pilot as part of the pivotal study

Pivotal investigation


Post market Surveillance

program

Type of study

Pilot investigation





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DESIGN

Part 4


Type of study

Objectives / endpoints

Pilot investigation




Defining the design

Operationalise the broad strategy

• Understanding the device to be studied

• Unmet need

• Phase of development

• Environment

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Type of study


Pilot investigation




Defining the design


• Unmet need

• Benefits, risks, importance, market

size, idiosynchracies

• Narrow down therapeutic area where

needed

• Cross Medical speciality lines i.e. who

needs to be addressed/involved

• How does the new device address the

unmet need similar or different from

standard of care?


Type of study


Pilot investigation




Defining the design



• Prototype

• Frozen design

• Is design likely to change during the

investigation?

• Influences the timelines

• Type of study

• Need for amendments – delays

• Does your device changes standard of

care

• Usually requires more data to

convince users

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Type of study


Pilot investigation




Defining the design



• Does your device influences/changes

surgical technique habits of the user

• If so, foresee training and

• Include sub-analysis for first use

by each new investigator.


Type of study


Pilot investigation




Defining the design


• Environment

• Classification of the device

• Innovative or ‘me-too’

• Impact on regulatory strategy

• Choice of control group

• Company – start up of large

multinational

• Competitors – availability of experts

• Reimbursement – payor acceptance

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Type of study


Pilot investigation




Defining the design


• Basis for endpoints

• Critical literature review

• Methods/results

• Define acceptable results

• Understand safety issues and

pitfalls

• Risk analysis

• Define possible safety issues

• Define possible technical issues

• Summary of safety and effectiveness

from US regulatory filings on other

devices


Type of study


Pilot investigation




Defining the design


• Basis for endpoints

• Clinical input from experts

• FDA website for guidance documents

• Vertical standards – product specific

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Type of study


Pilot investigation




Defining the design


• If control group is involved, how to choose?

• How comparable is invasiveness?

• How comparable is the procedure

involved?

• How will patients or Investigators

accept a control group?

• What are the risks involved?

• What are the pre-requisites to enter

the study – be randomized?

• Do we want to show ‘equivalence’,

‘non-inferiority’ or ‘superiority’


Type of study


Pilot investigation




Defining the design


• What are the parameters

• Objective

• Subjective

• Device operator

• Patient questionnaires

• When are they best measured and do

these interfere with standard patient

care

• Are measurements reproducible i.e.

variability or error in measurments

versus expected difference of control

group (if involved)

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Type of study


Pilot investigation




Defining the design


• Define a quantifiable change in a

parameter over a specified time or at a

specified time post procedure for a specific

percentage of patients

• e.g. how to define ‘no neurological

deficits’

• Motor vs sensory or both

• How much change is expected at what

timepoint and how long do the

symptoms last


Type of study


Pilot investigation




Defining the design


• Carefull with objectives such as ‘absence

of’ or ‘freedom from’ – if zero expectations

then failure is likely

• Define reasonable objectives

• IVD – set false positives and false

negatives at reasonable levels. Again zero

levels will lead to failure

• Base reasonable success criteria on early

results of pilot investigations if available

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Type of study


Pilot investigation




Defining the design


• Involve statistics

• Extrapolate early pilot data to larger

scope

• Set goals for comparing endpoints i.e.

equivalence, non-inferiority, superiority

• Consider larger sample size with better

chance on success criteria versus cheaper

trials with more risk

• Avoid over-optimisme usually induced by

marketing or management. Better exceed

endpoints than fail to get approval


Number of subjects

Statistical

significance …

… can be identified trough pilot

studies with limited subjects

Type of study


Pilot investigation


Number of subjects



Defining the design

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Duration of follow up

Follo

w u

p

Sufficient duration to reach the objectives and collect data on the endpoints.

Do not shorten timelines, need to cover the necessary follow up covering duration of device

contact with the body

Based on conclusions of the risk analysis.

Type of study


Pilot investigation


Number of subjects




Defining the design



Lon

g f

ollo

w u

p

The expected drop out rate

Severity disease Long follow up

Important drop out rate

Drop out rate can be 0% if the disease is low

risk, and follow up short term.

Type of study


Pilot investigation


Number of subjects




Sho

rt f

ollo

w u

p

Defining the design

&

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Eligibility criteria

If no data exist or limited follow up available, foresee further post market

clinical follow up data.

The patient population of a pre-market approval study is a small limited representation of the real

market population

Type of study


Pilot investigation


Number of subjects





Defining the design


Content according to ISO 14155

A synopsis

The document identification

Sponsor name and address

Identification of the participating sites

A full description of the device

The justification for the design of the clinical investigation

Risks and benefits of the investigational device and clinical investigation

Objectives and hypotheses

Clinical Investigation Plan

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Design of the clinical investigation

Devices and comparators


Criteria for withdrawal

Point of enrolment

Total expected duration

Expected duration of subject involvement

Total number of subjects

Enrolment duration




Procedures involved

Monitoring plan

Statistical considerations

Data management and quality control of data

Management of amendments of the CIP

Handling of deviations from the CIP

Device accountability process

Statements of compliance

Informed consent process

Safety reporting


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Conditions and process for including vulnerable populations (if applicable)

Process of suspension or premature termination of the clinical investigation

Publication policy

Bibliography



Amendments to the CIP

Some amendments are study wide applicable

Some specific amendments for a given site will lead to subgroup analysis


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Contents need to correspond with the data in technical file

Document identification

Name and address of the sponsor/manufacturer

Current design of the device with accurate technical specifications

All pre-clinical data

Existing clinical data

Risk management

Reference to appropriate standards and guidance documents

The

Investigator

brochure

Investigator brochure


Reflect design changes

Provide the necessary pre-clinical data for each design change

Justifies if design changes with no additional pre-clinical investigations

The

Investigator

brochure

Updates with safety data obtained during a clinical investigation


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The

Investigator

brochure

Foresee periodic reviews of the investigator brochure

Include review of serious adverse events and serious adverse device effects + recall

A review process must be in place during any clinical investigations



Regulatory Authority Notification File

Clinical Investigation plan

Investigator Brochure

Informed consent in national language

Copy of the Case Report Form

Clinical Investigation Insurance Certificate (includes product liability and clinical trial insurance)

Relevant proof of Investigator qualification

CV of Principal Investigator

Certificate of competence (laboratory or other imporant ancillary departments)

Copy of favourable opinion of the IRB/EC

Identification of legal representative (foreign Sponsors)

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Import licenses

Europe labelling ‘for clinical trial use only is sufficient’

Identification of manufacturer and sponsor (if different from manufacturer)

List of countries where the investigation is being performed

Copy of the clinical investigation agreement (between Sponsor and Investigator detailing roles and responsibilities)

FDA requires a list of IRBs and responsible persons

If devices are sold, FDA requires a justification for the price



EU requires a statement of compliance to the essential requirements (MDD Annex VIII §2.2)

Must comply with ISO 13485 but certification may be pending

Copy of labelling including instructions for use

Copy of the risk analysis

Identification of institutions involved

Core labs

Centralised laboratories

Data Monitoring Committee

Critical Events Committee

Amendments of documents already submitted

Progress reports (usually every 6 months)


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CONDUCT

Part 5


Initiation of the clinical investigation

Before initiation visit:

written approval / favorable opinion

of the EC

if required, regulatory approval

EC approval

Patient recruitment

Initiation visit Early start

Non-compliance

Personnel training

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Monitoring

Monitoring plan must contain activities to

ensure compliance with

CIP

ISO 14155

Other applicable guidelines

Ethics committee and regulatory

requirements

Monitoring activities

Activities of the monitor

Frequency of the activities


Monitoring

Monitors must be trained on

Investigational device and

procedures involved

Clinical environment, specifics of the

disease, complications etc.

Clinical investigation plan,

investigator brochure

ISO 14155:2011 and applicable

regulations

Monitors compared to pharma studies are

Much more involved in the product

handling

Must be able to provide guidance to

Investigational site personnel about

the investigational medical device

handling and procedures involved

Must be able to detect use errors,

know what to do in case of

malfunctions

Familiar with safety and device

deficiency handling.

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Classification of adverse events

Classification Criteria

Related vs.

unrelated to

the device/ procedure

Non-serious

vs. serious

outcome

Anticipated

vs.

unanticipated

Safety reporting



Related vs.

unrelated to


Non-serious

vs. serious

outcome

Anticipated

vs.

unanticipated

Classification of adverse events – Device related / procedure related /

unrelated

Safety reporting

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Non-serious

vs. serious

outcome

Anticipated

vs.

unanticipated

Classification of adverse events – Device related / procedure related /

unrelated

Related vs.

unrelated to


Adverse device effect

Adverse event related to the use of a medical device

Results from:

Insufficiencies or inadequacies in the instructions for use,

the deployment, the implantation, the installation, the

operation or any malfunction of the medical device.

User error or intentional misuse.

Safety reporting



Related vs.

unrelated to


Anticipated

vs.

unanticipated

Classification of adverse events - Non-serious vs. serious outcome criteria

Non-serious

vs. serious

outcome

The event led to:

Death

Serious deterioration in subject’s health

Fetal distress, fetal death, congenital

abnormality, birth defect

Life-threatening illness or injury

Permanent impairment of body

structure or a body function, or

In-patient hospitalization or

prolongation of existing

hospitalization

Medical or surgical intervention

to prevent life threatening illness

or injury or permanent

impairment of a body structure or

a function

Safety reporting

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Related vs.

unrelated to


Non-serious

vs. serious

outcome

Classification of adverse events –

Anticipated vs. unanticipated

Anticipated

vs.

unanticipated

Any event which is not listed as expected in the CIP, risk analysis,

investigator brochure or instruction guidelines is unanticipated

Unanticipated is usually only used for serious device related events

Safety reporting


Subject involved?


Adverse event decision tree

Yes

No

Yes

No

Yes

No

Yes

No

Yes

Un- anticipated?

ASADE

AE

ADE

USADE

SAE

Serious?

Serious?

Device Related?

Adverse event decision tree:

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Adverse event decision tree

Not adverse event as nothing happened to the subject


Timelines - Investigator

Timelines are crucial:

Investigator Sponsor and EC/IRB

Can get serious remarks from their EC

An ‘immediate’ reporting rule should be

applied

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Timelines - Sponsor

Timelines are crucial:

Investigator Sponsor and EC/IRB

Sponsor

Regulatory authorities

Critical events committee, data

monitoring committee

May request to suspend a CI for safety reasons

Should sets up a good communication system


Decision/

Trend

analysis

Multiple-centers reporting

Investigators

Critical events committee

(CEC)

Sponsor Data

monitoring committee

(DMC)

Guarantees the overall

continuing safety of subjects

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6.5.1 Documents and

documentation amendments

Justification needs to be given for any

amendments to essential documents

Amendments must be approved

between sponsor, investigator and

coordinating investigator

Amendments must be notified to ethics

committees and, where appropriate, to

regulatory authorities

Amendments must be clearly identified

by version number and date

Coordinating investigator

Investigator who is appointed by the sponsor to coordinate work in a multicentre clinical investigation.

Clinical Investigation Documents and Documentation Amendments


6.5.2 Documents and documentation

subject identification log

Log identifying subjects enrolled links

identification code to subject name or

other means of identification

Contains confidential data

Must remain on the site

Subject Identification Log Traceability of all subjects

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6.5.2 Documents and documentation

subject identification log

Written procedures

Records of compliance of all parties

Ensure auditing requirements

Justify any exceptions made to the ISO

14155 requirements

Integrate into Manufacturers overall

Quality System ISO 13485

Clinical Quality System Compliance and success


Device Accountability

Device accountability records include

date of receipt

identification of each investigational

device (batch number, serial number

or unique code)

expiry date, if applicable

date of use with the subject’s

identification

date returned/explanted from subject,

if applicable

date of return of unused, expired or

malfunctioning investigational

devices, if applicable

In most cases written procedures are needed!

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Final version

Based on all versions of the clinical investigation plan

Provide an overview of all amendments

Coherence between conclusions in the clinical report and

objectives and endpoints stated in the clinical investigation


Author

Scientific competences and technical understanding of the device.

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Notifications

Ethics committees

Regulatory authorities


CLINICAL EVALUATION

POST MARKET SURVEILLANCE

Part 6

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Definition

Post market surveillance is proactive in order prevent or

minimize harm to patients.

A methodology including expert involvement in the interpretation of the

data is in place

Collection of the data is done according to a well defined plan


Post market surveillance activities

May vary and are mainly dependent on the risk level of the product itself.

Vigilance reporting

Vigilance reporting is an output of post market surveillance


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Post market surveillance activities – IMPORTANCE!

Decision to conduct PMS Innovativeness Severity of disease Sensitive target

population Risky anatomical

location Well known risk Lack of long term data


3 2

Post market surveillance plan 4

Link your post market surveillance to the risk

analysis

From pilot to mass production

Think of this as a continuous improvement process

Steps to ensure we close the loop and setup an active PMS plan

1

Risk Analysis

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Knowledge is

essential to ensure

compliance and fast

track to market

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Year 1 Year 2 Year 3

New / changedrequirements per year

Existing / maintainedrequirements

Continuing education

Gap!

20% increase in knowledge requirements annually.


• Non-compliance issues

• Risk of delayed market access

• Ineffeciency, loss of productivity

The Problem:

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Efficiency

Velocity

Timeliness

Consistency

E-learning allows learners to cover the same material

in half the time of instructor-led training

Training can be deployed on-demand within minutes –

not weeks or even months

Learners receive what they need – when they need it

Quality of training delivered is consistent and

continuously updated

Why Online Learning?

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Course Catalogue

Learning Center

Courses & Exercises

Quiz


ISO 14155: In Depth Review

The medical device industry’s most trusted source for professional online training.

7 Course Suite WMDO has created especially for medical device professionals the powerful online training suite: “ISO 14155: In Depth Review” to get you up and on the right track now. Developed by WMDO clinical expert and TC 194 WG4 convener for ISO 14155, Danielle Giroud , WMDO is proud to offer a powerful suite of seven online courses packed with 3.5 hours of valuable, up-to-date information and knowledge resources on the new ISO 14155. These seven online courses provide crucial guidance and support for medical device professionals working in clinical, quality, and regulatory roles responsible for compliance to ISO 14155. The WMDO ISO 14155 courses not only provide a description of the new standards, but also offer a practical guide on how to implement and become compliant to the new requirements, including real-life examples.

Be sure to check out the online course:

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ISO 14155: 2011 A Summary Review


For all medical device professionals on the go who are short on formal knowledge concerning the latest revision of the ISO 14155, but who do not require the comprehensive or in-depth details as found in the 7 course suite: ISO 14155: In Depth Review, WMDO proposes this condensed yet inclusive summary review of the standard to get them up to speed. ISO 14155: 2011 A Summary Review will provide you with an understanding on when to apply the ISO 14155 requirements, what are the basics of the ethics requirements, a list of essential tasks and elements during preparation, conduct and closing a clinical investigation with a brief explanation of the main responsibilities of the sponsor and investigator.


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ISO 14155 Version 2003 vs. 2011:

Gap Analysis


The ISO 14155:2011 has been published with many new requirements

compared to the previous version and contains major changes that will have a

significant impact on the clinical quality systems and related documents such

as case report forms and clinical investigation plans, informed consents and

investigator brochures and more.

Clinical and quality assurance managers should not underestimate the work

needed to incorporate all the changes brought with the ISO 14155:2011. To

help you with this tedious exercise, WMDO has created the ISO 14155

Version 2003 vs. 2011 Gap Analysis that will clearly lead you through the

hundreds of changes across more than 175 posts between the two

documents. This comprehensive and valuable resource will help you save

significant time and effort in completing the upgrade of your clinical quality

system.

Save Time and Eliminate Errors With New Gap Analysis!

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Risk Management for Medical

Devices in the EU & US


3 Course Suite This suite has 3 courses. Course one is a review of the risk management standard ISO 14971-2007. Course two explains how to prepare a Risk Management File and which techniques apply. Course three shows how to integrate Risk Management into the Quality System. Learn to identify, implement, verify and maintain risk control measures to reduce risk associated with medical devices to an acceptable level.


www.wmdo.org

Available now at:


Adverse Event Processes


This course provides you with an expert review of the overall regulatory requirements according to ISO 14155 and EU and US requirements. It provides a basic overview of how to consider adverse events in clinical investigations and how to effectively record, report and analyze the data.


www.wmdo.org

Available now at:

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Safety Related Committees

Establishment


2 Course Suite Throughout the years, it became apparent that an unbiased independent approach was needed to ensure that ethics and patient protection was applied in clinical studies; hence the development of the various safety related committees: CEC and DSMB. Professionals interested in establishing a safety related committee, specifically CEC/DSMB, will find this suite of courses particularly informative and helpful as it will provide you with extensive details on not only what a CEC/DSMB is and what it does, but also how a CEC/DSMB functions; including its roles and responsibilities as well as a review of the standards and regulations by which clinical trials are conducted and CEC/DSMB database management.


www.wmdo.org

Available now at:


Clinical Evaluation for Market

Approval and Clinical Trials


3 Course Suite Manufacturers planning to market their devices in Europe are now required to furnish clinical data in line with the new European Directives that came into effect as of March 21, 2010. This intensely comprehensive 3 course suite on Clinical Evaluation for Market Approval and Clinical Trials will empower you with the essential information, requirements and guidelines you need to successfully and accurately conduct clinical evaluation under the new European Directives. From regulatory process and compliance to literature review and conformity; get on the right track to market approval today.


www.wmdo.org

Available now at:

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Device-ified?

Now get certified!


The WMDO Certification Program provides a unique opportunity for medical

device professionals from around the world who are seeking formal

recognition of knowhow tailored exclusively to the specific needs of the

medical device industry.

Applications for Certified Medical Device Associate (CMDA) in clinical

evaluation are now being accepted

Pre-registration:

Candidates wishing to apply for CMDA certification in clinical evaluation may do so now by pre-registering at wmdo.org.

WMDO CERTIFICATION PROGRAM

www.wmdo.org Pre-register now at:


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For more information:

www.wmdo.org

Or contact

[email protected]

Anytime. Anywhere. Anyone. Medical device training the way it’s supposed to be.

http://www.wmdo.org/

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