New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New...
Transcript of New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New...
![Page 1: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/1.jpg)
New product standard: IEC 82304-1Fill the gap!
(C) 2
016 Q
Advis
AB
![Page 3: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/3.jpg)
QAdvis team
(C) 2
016 Q
Advis
AB
![Page 4: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/4.jpg)
QAdvis key competence areas
QMS in-the cloudTurn key quality systemsSharepoint based Digital signaturesEfficient and leanValidated and compliant
System developmentProject managementProduct software validationRegulated software validationRequirement managementRisk managementVerification and validationProcess validation
QA&RA/Clinical ConsultingInterim managementExpert advise Audits/Mock audits/assessmentsWarning letter, compliance projectsPMA, 510k, CE‐mark, EC‐certGlobal regulatory supportVigilance, recall, post market survyClinical evaluation/clinical study
Training/coursesCE‐markingISO 13485IEC 62304 & IEC 82304‐1IEC 60601‐1SW life cycleSW risk managementFDA’s QSRRisk management Etc
Lean and Six SigmaTraining and ConsultingIn cooperation with Oriel Stat‐A‐Matrix Inc.
European AuthorisedRepresentationProviding European representation for non‐EU MedTech companiesActive member of EAAR: European Association of Authorised Representatives
(C) 2
016 Q
Advis
AB
![Page 5: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/5.jpg)
Agenda
• Background• Scope• Content • Relations to other standards• Status
(C) 2
016 Q
Advis
AB
![Page 6: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/6.jpg)
• IEC 60601 - series of technical standards for the safety and effectiveness of medical electrical equipment
• Covers PEMS Programmable Electrical Medical Systems
Background
(C) 2
016 Q
Advis
AB
![Page 7: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/7.jpg)
Background
(C) 2
016 Q
Advis
AB
![Page 8: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/8.jpg)
Background
• 60601-1, ed. 3, 2005 => 60601-1, ed. 3.1, 2012
(C) 2
016 Q
Advis
AB
![Page 9: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/9.jpg)
Background
• New standard needed! => IEC 82304-1
Clause 14PEMS
Clause 18, “standalone SW”
(C) 2
016 Q
Advis
AB
![Page 10: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/10.jpg)
Scope
1. SW for general computing platforms
2. Health software products3. Safety & security4. Manufacturers5. Entire lifecycle
(C) 2
016 Q
Advis
AB
![Page 11: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/11.jpg)
Scope
SW for general computing platforms• Standalone software• Software medical device• Software-only products• SaMD, Software as a Medical Device• SaaS, Software as a Service
(C) 2
016 Q
Advis
AB
![Page 12: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/12.jpg)
Scope
Health
WHO definition: “Health is a state of complete physical, mental and social well‐being and not merely the absence of disease or infirmity” (WHO, 1946)
(C) 2
016 Q
Advis
AB
![Page 13: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/13.jpg)
Scope
Health softwareSoftware intended to be used specifically for managing, maintaining or improving health of individual persons, or the delivery of care
(C) 2
016 Q
Advis
AB
![Page 14: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/14.jpg)
Scope
SafetyFreedom from unacceptable risk
SecurityProtection of information and data so that unauthorized persons or systems cannot read or modify them and authorized persons or systems are not denied access to them(C
) 201
6 QAdv
is AB
![Page 15: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/15.jpg)
Scope
ManufacturerNatural or legal person with responsibility for the design, development, packaging, or labelling of a health software product, or adapting a health software product before it is placed on the market or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party
(C) 2
016 Q
Advis
AB
![Page 16: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/16.jpg)
Scope
Entire lifecycle• Design• Development• Validation• Installation• Maintenance• Disposal
(C) 2
016 Q
Advis
AB
![Page 17: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/17.jpg)
Content
Product standard
(C) 2
016 Q
Advis
AB
![Page 18: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/18.jpg)
Content
(C) 2
016 Q
Advis
AB
![Page 19: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/19.jpg)
Content
• Requirements specification• Software life cycle processes• Validation• Identification• Accompanying documents• Post-market activities
(C) 2
016 Q
Advis
AB
![Page 20: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/20.jpg)
Content
• Intended use• Product risk assessment• Use requirements• System requirements
§4 Health software product requirements
(C) 2
016 Q
Advis
AB
![Page 21: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/21.jpg)
Content
(C) 2
016 Q
Advis
AB
![Page 22: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/22.jpg)
Content
IEC 82304-1
IEC 62304
(C) 2
016 Q
Advis
AB
![Page 23: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/23.jpg)
Content
• Address Use requirements• Plan• Perform• Report
§6 Health software product validation
(C) 2
016 Q
Advis
AB
![Page 24: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/24.jpg)
Content
• Manufacturer name / trademark• Product name / type reference• Version identifier
§7.1 Health software product identification
(C) 2
016 Q
Advis
AB
![Page 25: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/25.jpg)
Content
• Manufacturer contact information• Product identification• Version• Instructions for use• Technical description
§7.2 Health software product accompanying documents
(C) 2
016 Q
Advis
AB
![Page 26: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/26.jpg)
Content
• Health software description• Warnings and notices• Installation• Start-up procedure• Shut-down procedure• Operating instructions• Messages• Decommissioning and disposal• Technical description
§7.2.2 Instructions for use
(C) 2
016 Q
Advis
AB
![Page 27: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/27.jpg)
Content
• System requirements• Details of the supported SW platforms• Environmental conditions transport/storage • Characteristics• Installation requirements/restrictions• Maintenance• Technical security options• Detection of security breach
§7.2.3 Technical description
(C) 2
016 Q
Advis
AB
![Page 28: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/28.jpg)
Content
• Technical specification, characteristics & configuration
• Information flow• Hazardous situations• Risk information
§7.2.3.2 Use in non controlled IT network
(C) 2
016 Q
Advis
AB
![Page 29: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/29.jpg)
Content
• Maintenance• Re-validation• Post-market communication• Decommissioning and disposal
§8 Post-market activities
(C) 2
016 Q
Advis
AB
![Page 30: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/30.jpg)
Content
• Errors impacting safety and/or security
• Modifications
§8.2 Maintenance
IEC 62304
(C) 2
016 Q
Advis
AB
![Page 31: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/31.jpg)
Content
§8.3 Re-validation
• Affected parts• Update Validation plan• Supported HW/SW platforms
(C) 2
016 Q
Advis
AB
![Page 32: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/32.jpg)
Content
§8.4 Post-market communication
• Security vulnerabilities• New releases• Upgrade or not
(C) 2
016 Q
Advis
AB
![Page 33: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/33.jpg)
Content
§8.5 Decommissioning and disposal
• Safeguarding personal and health-related data
• Use requirements
(C) 2
016 Q
Advis
AB
![Page 34: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/34.jpg)
Relations to other standards
• IEC 60601, IEC 61010, ISO 14708• IEC 62304 • ISO 14971• IEC 80001-1, IEC 80001-2-2• IEC 62366-1
(C) 2
016 Q
Advis
AB
![Page 35: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/35.jpg)
Status
Next step
• FDIS, Sep 02, 2016• Voting ends Oct 14, 2016• Publication, Dec 2016
(C) 2
016 Q
Advis
AB
![Page 36: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/36.jpg)
Status
Next step
• Harmonized standard?
(C) 2
016 Q
Advis
AB
![Page 37: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/37.jpg)
QAdvis can support you as needed
IEC 82304-1
• Gap analysis
• Implementation
• Compliance assessment
• Training
• Performing specific activities e.g.
software risk management Contact:[email protected]@[email protected]
www.qadvis.com
(C) 2
016 Q
Advis
AB
![Page 38: New product standard: IEC 82304-1 2016 (C)media.qadvis.com.loopiadns.com/2016/10/82304... · New product standard: IEC 82304-1 Fill the gap! (C) 2016 ... PMA, 510k, CE‐mark, EC‐cert](https://reader031.fdocuments.us/reader031/viewer/2022012313/5a7093377f8b9a98538c25dc/html5/thumbnails/38.jpg)
Thank youQuestions & Answers
(C) 2
016 Q
Advis
AB