Company Information Form - BSI Group€¦ · Page 1 of 11 MDF7300 Issue 1 Company Information Form...
Transcript of Company Information Form - BSI Group€¦ · Page 1 of 11 MDF7300 Issue 1 Company Information Form...
Page 1 of 11 MDF7300 Issue 1
Company Information Form Medical Devices
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Let BSI help you meet the world with confidence. Our mission is to ensure patient safety while supporting timely access to global medical device
technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications.
In order to start our quotation process we need certain information. For this purpose, we kindly request you to fill out the questionnaire below.
(This form can be completed and submitted using Adobe Acrobat Reader, alternatively please print clearly).
Company Information Form
Section A: Company Information.
Legal Company Name:
Address:
Country: Website:
Regulatory Correspondent:
Primary contact: Secondary contact:
Name: Name:
Position: Position:
Tel: Tel:
Fax: Fax:
Mobile: Mobile:
Email: Email:
Is your company part of a larger organization? If so, please give details of the organization:
Do you trade under any other trading names? If so, please give further details:
Authorised European Representative: (if company not resident in EU)
Legal Company Name:
Representative Title/Name/Position:
Consultants:For the products and services listed within this form, will you be using or have you previously used a Consultant to help you in your design,
construction, marketing or maintenance of the products, processes or Quality Management Systems? Yes No
(If applicable, please complete their details below)
Consultant name:
Address:
Email: Tel:
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Company Information Form Medical Devices
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Section B: Services requested
Please select the services you would like BSI to provide a quotation or provide information? For a description of these services please refer to the
annex at the back of this pdf or ask your sales representative for more information.
Medical Device Related Services:
Initial application Transfer from another Notified Body/Certification Body
CE certification to MDD, AIMD Directive Medical device or quality system related training
ISO 13485:2016 (UKAS) Safety testing (IEC 60601 and/or EMC)
ISO 13485:2016 (RvA) Australia TGA/EU MRA Fast Track Service
(Applicable only to products manufactured in Europe)
ISO 13485:2016 (SCC) Japan PMD Act certification
Malaysia CAB product approval
Medical Device Single Audit Program (MDSAP)
Accelerated Medical Device Registration in
Taiwan (Applicable only to EU Manufacturers)
ISO 9001:2015 (UKAS)
Hong Kong CAB product approval ISO 9001:2015 (ANAB)
Saudi Arabia CAB services (Information only)
CE Marking Technical Documentation Review Services:
Please select which technical documentation review service you would like to receive a quotation for?
CE-Standard
CE-Dedicated FastTrack
CE-Onsite FastTrack
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Company Information Form Medical Devices
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Section C: Information required for quality system assessmentPlease complete this section if you are applying for ISO 13485/9001 and CE certification. In case of CE marking, please also complete section D (product information).
Company Organization:
If the company consists of several locations all contributing to the overall scope of any proposed application then please complete this section. Please
clearly indicate where design, manufacturing, sterilization etc take place. Use an additional sheet if necessary.
Site Details: Main Site
Name:
Address:
Functions/Activities:
Number of employees: Shift system (hours/number of shifts/number of employees per shift):
Site Details: Second Site
Name:
Address:
Functions/Activities:
Number of employees: Shift system (hours/number of shifts/number of employees per shift):
Site Details: Third Site
Name:
Address:
Functions/Activities:
Number of employees: Shift system (hours/number of shifts/number of employees per shift):
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Company Information Form Medical Devices
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Existing Certificate Details:
Please provide copies of any CE marking or ISO 13485 certificates held.
Main Site Second Site Third Site
Certificate Number:
Certificate Type:
Issuer of Certificate:
Current Certification Scope:
Materials:
Please indicate the material base of your products: Plastic Metal Organic Other
New Applications:
Suggested scope of certification of your quality system:
Client Readiness:
When will your QMS be ready for assessment?
When will your technical documentation be ready for assessment?
Main Site Second Site Third Site
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Company Information Form Medical Devices
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Section D: Information required for CE certification.
Please complete this section if you request a quotation for CE certification.
90/385/EEC – AIMD (Active Implantable Medical Devices)
93/42/EEC – MDD (Medical Devices)
Route to Conformity Which conformity assessment procedure(s) would you like to follow?
MDD or AIMD – Annex II (Full Quality System) MDD – Annex IV (EC Verification) MDD – Annex III (Type/Design Examination)
MDD – Annex V (Production Quality System) MDD – Annex VI (Product Quality System)
Product Details:
Please give details of the devices to be included in the scope of this application. Copies of any product literature should be included.
Device Name Device Description/ Classification Rule Justification for Is the device Sterilization Sterilization
Intended use Classification sterile? Yes/No Method Location
(please also indicate if in-house or sub- contracted)
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Company Information Form Medical Devices
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Magnetic Resonance Compatibility:
Is the device specified for use in the MR environment? Yes (MR Safe/MR Conditional) No (MR Unsafe)
Software:
What is the software classification according to EN 62304? A B C
Accessories: If any accessories are included, please give details whether sold with the product or separately:
Special Materials:
Does the device(s) contain any medicinal substances or human blood derivatives? Yes No
If YES, please give details of medicinal substance including name, sourcing, availability of ASMF or CEP, previous consultations held with a
national Competent Authority or EMA. If the substance is considered as non-liable to act on the human body as presented in the device, please provide a
justification for this as a separate document
Does the device(s) contain or utilize any non-viable animal tissues or derivatives? Yes No
If YES, please indicate the tissue/derivative, country of origin (sourcing country) and EDQM certificate details (if applicable)?
Special Processes:
Please give details of any special processes carried out e.g. Sterilization:
Please indicate brand/method of sterilization:
Has/have the sterilization validation(s) been completed? Yes No
If No, please indicate the expected date of completion:
Has/have the shelf life and expiry dating validation(s) been completed? Yes No
If No, please indicate the expected date of completion:
Is the device intended for sterilization by the end user? Yes No
Are the instructions for sterilization and cleaning included in the IFU? Yes No
Have the instructions for sterilization and cleaning been validated to support the IFU? Yes No
Novelty:
Is the device a new development to the market? Yes No
Does the device feature any novel features such as materials, technologies or intended use?
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Sub-contractors:
Are any processes sub-contracted, e.g. design, manufacturing, sterilization, cleaning, packaging, servicing, vigilance, post market surveillance, QC Testing?
If so, please specify activity, to whom they are sub-contracted and details of any quality systems held by the sub-contractor.
Contact: Sub-contractor 1
Name:
Address:
Activity Sub-contracted:
Existing Registrations?
Please confirm whether you have provided copies of certificates: Yes No
Contact: Sub-contractor 2
Name:
Address:
Activity Sub-contracted:
Existing Registrations?
Please confirm whether you have provided copies of certificates: Yes No
Contact: Sub-contractor 3
Name:
Address:
Activity Sub-contracted:
Existing Registrations?
Please confirm whether you have provided copies of certificates: Yes No
Additional Information:Please use this area to provide any additional information including audit language requirements which you think would be helpful in progressing
the quotation process:
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Company Information Form Medical Devices
Please return this form to BSI with a copy of your standard company information, the product brochures and any other information which you
think would be helpful in the quotation process.
Declaration:The applicant herewith declares to have lodged no application with any other Notified Body for the same device-related quality management
system.
The applicant herewith declares to have lodged no application with any other Notified Body for the same device(s).
The applicant herewith confirms that the information provided in this application is true and correct.
Name of Applicant:
Position of Applicant:
Signature: Date:
Visit us online at: bsigroup.com/medical
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Company Information Form Medical Devices
Annex: Description of services.
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CE marking
CE marking is the medical device manufacturer’s claim that a product
meets the essential requirements of all relevant European Directives
and is a legal requirement to place a device on the market in the
European Union. The three medical devices directives are:
• Medical Devices Directive (MDD)
• Active Implantable Medical Devices Directive (AIMDD)
• In Vitro Diagnostics Directive (IVDD)
The EU Medical Device Directives are Changing, BSI can provide further
information on the changes via our transition pages:
bsigroup.com/IVDR-revision and bsigroup.com/MDR-revision.
Australia – Conformity Assessment Body (CAB)
Importers of medical devices in Australia need to meet the
requirements of the Therapeutic Goods Administration of Australia.
BSI is designated as a Conformity Assessment Body under the Mutual
Recognition Agreement (MRA) between EU and Australia.
Japan – PMD Act and PMDA approval Pharmaceutical and Medical
Device Act (PMD Act) regulation.
The distribution of medical devices in Japan is regulated in accordance
with the Pharmaceutical and Medical Device Act (PMD Act) regulation
by the Ministry of Health, Labour and Welfare (MHLW). The former
regulation, Japanese Pharmaceutical Affairs Law (JPAL) was replaced
by PMD Act on November, 25, 2014. The revision includes third party
certification systems for Class III medical devices and expansion of the
responsibility of quality management system to legal manufactures.
Because of the complexities of PMD Act and the involvement of
Japanese and international governmental bodies, we can help you
understand device classifications, prepare for the review process, and
help you meet standards.
Taiwan, Technical Cooperation Programme (TCP)
The TCP allows exchange of Medical Device GMP and ISO 13485 Audit
Reports between Republic of China, Department of Health Designated
Medical Device GMP Auditing Organizations and EU AIMD/MDD/IVDD
Notified Body Partners.
Hong Kong CAB
BSI was the first Hong Kong CAB under the Medical Device
Administrative Control System. Using BSI as your HK CAB means BSI
CE marking clients need only to submit a minimal amount of technical
documentation and companies can get the CE marking and HK
Registration with one assessment.
Malaysia CAB
As of the 1st of July 2013, the Malaysian Medical Devices Act 2012 (Act
737) will be fully enforced in the country, BSI has been approved as a
CAB. Working with a conformity assessment body is essential for any
medical device organization to register their medical device products,
be certified to a medical device quality management system or to
attain certification for their Good Distribution Practices for Medical
Devices (GDPMD).
Brazil
BSI Brazil has extended their scope of INMETRO accreditation to
include product certification to 60601 (safety of electro-medical,
active, devices). INMETRO 60601 product certification is mandatory
for electro-medical devices intended to be placed into Brazil before
the manufacturer can receive ANVISA regulatory market clearance.
As a INMETRO product certification body BSI Brazil can now receive
applications from manufacturers outside Brazil.
Transfer from another Notified Body
If you decide to transfer your certification to BSI, we can offer a
seamless exercise with comprehensive support and the absolute
minimum level of disruption. With expertise encompassing the full
range of industry sectors and management system standards.
Description of BSI Medical Device Related Services:
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Quality Management
ISO 13485 Quality Management
ISO 13485 is an international standard recognized for medical device
QMS registration. It helps manufacturers consistently manufacture
devices that are safe and fit for their intended purpose and meet
regulatory requirements for manufacturing control. BSI is an
accredited third party that conducts on-site assessments and makes
recommendations.
Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) is an international
initiative where Auditing Organizations (AO) can conduct a single audit
of a medical device manufacturer that would be accepted by multiple
regulators to address QMS/GMP requirements.
Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US
FDA and Japanese MHLW) have completed a three year MDSAP pilot
in 2016, the programme is now live. Health Canada has announced
that as of 1 January 2019, they will terminate their current CMDCAS
program and only accept MDSAP certificates.
ISO 13485 Pre-Assessment Service
An opportunity for a company to have an informal preliminary
assessment that will not affect the outcome of the registration.
This service will identify major flaws or gaps in the systems that the
manufacturer can then correct.
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CE Marking Technical Documentation Review Services:
CE-Standard
The CE-Standard review service allows you to work closely with your
assigned BSI Product Expert on your product certification. These
reviews are conducted remotely, with communication between you
and your BSI Product Expert via phone and email, as required.
CE-Dedicated FastTrack
The CE-Dedicated FastTrack review service allows you to schedule your
technical documentation review with a dedicated BSI Product Expert.
The review is conducted remotely via teleconferencing, allowing you to
engage with your dedicated BSI Product Expert and provide immediate
responses to their questions. This allows predictability in planning for
the review, and can improve the efficiency of the review process.
CE-Onsite FastTrack
The CE-Onsite FastTrack review service is conducted at your premises;
a BSI Product Expert visits the facility for a period of time. CE-
Onsite FastTrack reviews allow for dynamic communications and
opportunities for immediate responses to questions raised by the
reviewer. Planning a CE-Onsite FastTrack review in advance provides
you with more predictability and the reassurance of knowing when
your BSI Product Expert will be at your premises.
For more information on our CE-Excellence services visit:
Call: +44 345 080 9000 or visit: bsigroup.com/ce-excellence
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Company Information Form Medical Devices
Visit us online at: bsigroup.com/medical
Additional Resources:
Medical Device eUpdate Service
Keep updated on what’s happening in the industry and changes in
regulatory and quality requirements. You can take advantage of this
free service by signing up at our website.
Informative webinars
Hear regular updates from our experts on key topics; listen live or
listen back.
Comprehensive white papers
Our technical specialists collaborate with external experts to bring
you the latest views and understanding on complex regulatory issues.
Download your complimentary copies now.
Guidance documents
Our online guidance documents provide assistance in understanding
the regulatory requirements for medical devices.
Standards
BSI British Standards delivers leading-edge best practice solutions
through the development and publication of more than 34,000
standards and related products.: bsigroup.com/standards
Training
BSI’s range of course offerings is among the most comprehensive
available and addresses the needs of quality and regulatory
professionals. BSI offers public, onsite, e-learning and webinar training
courses. You can view courses at: bsigroup.com/medical-training
Join our Linkedin Group
https://www.linkedin.com/groups?gid=5100466
©B
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The trademarks in this material (for example the BSI logo or the word “KITEMARK”) are
registered and unregistered trademarks owned by The British Standards Institution in
United Kingdom and certain other countries throughout the world.
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