(C) QAdvis. IEC and IEC how to make them work (and why so much attention on SW) QAdvis RMD, Prague, November 8th 2016
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1 IEC and IEC how to make them work (and why so much attention on SW) QAdvis RMD, Prague, November 8th 2016
2 QMS in-the cloud Turn key QMS Digital signatures Efficient and lean Validated and compliant Training/courses CE-marking ISO & QSR IEC & IEC IEC IEC SW life cycle SW risk management Risk management And more IEC and IEC how to make them work QAdvis key competence areas System development Project management Product software validation Computer systems validation Requirement management Risk management Verification and validation Process validation Lean and Six Sigma Training and Consulting In cooperation with US partner. QA&RA/Clinical Consulting Interim management Expert advise Audits/Mocks/Due Diligence Warning letters, compliance projects PMA, 510k, CE-mark, EC-cert Global regulatory support Vigilance, Recalls, PMS Clinical evaluation and clinical studies European Authorised Representation Providing European representation for non-eu MedTech companies Active member of EAAR: European Association of Authorised Representatives
3 Presentation of the speaker Robert Ginsberg 30+ years in SW Development 25+ years in Medical Device SW Certified Lead auditor (ISO & QSR) Co-author to IEC 62304, 82304, , , Working member of Cenelek TK-62 Certified Scrum Master
4
5 What makes software so special? Easy to change Abstract, invisible Complex
6 When Sofie came into ER, the treating doctor used the wrong patient record. In the electronic patient record system at the hospital there were two patients with similar names and social security numbers. Based on the contents of the wrong record Sofie was treated with drugs that led to her death. IEC and IEC how to make them work Can wrong patient information contribute to death? Case report: Swedish SoS 2007 Swedish SoS = National Board of Health and Welfare Ref:
7 The bar is raised over time New laws and regulations Accident Public reaction People get hurt or die
8 Expectations from authorities are based on historical events o o o o Example: upcoming MDR & IVDR Objective evidence Software validation Device verification Device validation Safety and effectiveness Risk analysis Clinical evaluation Designated individuals responsible In-the-state-of-control
9 Standards play a central role in the regulatory environment
10 IEC 62304: Medical device software Software life cycle processes A SW process standard IEC and IEC how to make them work
11 ISO that defines the risk management process is the basis of IEC (Ed 1.1) Risk analysis Risk evaluation Risk control Residual risk Risk management report (Post ) Production Identification of Intended use Identification of Hazards, Hazardous situations and Harms Estimation of Risk(s) Option analysis Implementation of risk control measures Risk/benefit analysis Risks from risk control measures Service records & Complaints & Clinical data
12 IEC philosophy is based on three basic principles Quality Management Risk Management SW Engineering
13 Your validation effort should be dynamic regarding rigor and detail based on risk No risk low effort High risk high effort
14 Reviews Static testing Unit testing Integration testing System level testing User level testing IEC and IEC how to make them work Reading IEC how much is enough? Coverage of minimal process requirements Results from the risk analyses set the level of V&V The traceability assures and demonstrates coverage Field data supports your strategy A defendable story!
15 You should use field data to defend your story Modify product, etc Risk analyses Develop the product Monitor in field
16 IEC : Health software Part 1: General requirements for product safety How will it fit in next to other standards?
17 Relevant standards for SW as part of a medical device according to MDD Company Product Software ISO (QMS) IEC (PESS) ISO (Risk mgmt) IEC (Usability) IEC (SW process)
18 Relevant standards for SW as medical device (SaMD) according to MDD QAdvis Company ISO (QMS) Product Software IEC : Health Software Part 1: General requirements for safety(c) product safety IEC (SaMD) ISO (Risk mgmt) IEC (Usability) IEC (SW process)
19 The structure of IEC is aligned with system level standards as IEC and IEC User needs Product level activities - validation, documentation, etc User needs met
20 The scope of IEC (and IEC ed 2) is intended to also cover Health SW SW for specific HW, e.g. IEC SW for general purpose HW Medical Device SW SW as medical device Medical intended use Embedded SW for other health use Standalone SW for other health Use Other health use HEALTH SOFTWARE - software intended to be used specifically for managing, maintaining or improving HEALTH of individual persons, or the delivery of care
21 IEC is mainly a product standard for health software SW for general computing platforms Health software product validation Safety & security Manufacturers Entire lifecycle
22 IEC is for software running on general computing platforms SW for general computing platforms Standalone software Software medical device Software-only products SaaS, Software as a Service SaMD, Software as a Medical Device (IMRDF)
23 IEC is addressing safety and security Safety Freedom from unacceptable risk Security Protection of information and data so that unauthorized persons or systems cannot read or modify them and authorized persons or systems have access to them
24 IEC is expecting a manufacturer to be identified Manufacturer Natural 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
25 IEC is tightly interconnected with IEC 62304
26 IEC calls for health SW product identification Manufacturer name and trademark Product name and type reference Version identifier
27 IEC calls for health software accompanying documents Manufacturer contact information Product identification and Version Instructions for use Technical description
28 IEC Edition 2 is on its way (early 2018?) Usability Scope expansion - Health software Software Severity Classification evolved Security
29 What's next? MDR and IVDR IEC and IEC how to make them work
30 There is a new classification rule in MDR for software 10a Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, is in class IIa, except if such decisions have an impact that may directly or indirectly cause: - the death or an irreversible deterioration of the state of health, in which case it is in class III; - a serious deterioration of the state of health or a surgical intervention, in which case it is in class IIb. Software intended to monitor physiological processes is in class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, in which case it is in class IIb. All other software is in class I.
31 Summary IEC and IEC how to make them work Focus should be on design, defect prevention and SW reliability A solid approach to software risk management is fundamental Software architecture and design Usability Security Tool support is crucial to achieve high productivity in SW development Static analysis Test automation Risk and requirements management Field data needed as part of your defendable story The regulatory storm is ahead of us. Don t wait act now!
32 Q&A
33 QAdvis can support you as needed IEC and IEC Gap analysis Implementation Compliance assessment Training Software risk management Static analysis program Tool implementation EAR services
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