IEC 62304 An introduction the Software Life Cycle for Medical Devices Version 04 Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 1 Content • The IEC62304 and its environment • SW Classification • IEC62304 implementation • The IEC62304 step by step • General Requirements • Software Development • Software Risk Management • Software Configuration Management • Software Problem Resolution • Software Maintenance • SOUP Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 2 But first who is who….. • Willem vd Biggelaar • Quality and Medical Regulatory Consultant for 15 years now • Certified DEKRA auditor for ISO 9001 / ISO 13485 • Setup ISO 13485 certified Quality Management Systems (QMS) • Previous jobs • Quality Assurance Officer (5 years) • System Tester (1 year) • Embedded software engineer (7 years) • And you? Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 3 The IEC62304 and its environment Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 4 Just to set the scope…….IEC62304:2006 v1.0 • Is the de-facto process standard for the development of medical device software • New 2.0 version on it’s way, version 1.1 already available but not harmonized Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 5 Recognized by major markets (EU, USA, China) Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 6 Regulatory framework Harmonized Standards presume conformance to GSPR Generic Product Standards examples Process Standards IEC 60601-1 Electrical Safety ISO 13485 QMS for MDR contains GSPR medical devices IEC 60601-1-2 EMC Regulatory Medical Device requirements ISO 14971 Risk IEC 60601-1-6 Usability Management European Medical Satisfy Fulfill Devices Regulate Particular Product Standards Regulation (2017/ IEC 62366 Useability examples 745/EC) Engineering IEC 60601-2-10 safety of nerve and muscle stimulators IEC 62304 Software Life Mandatory. You have to comply cycle IEC 60601-2-57 Non-laser light source equipment IEC 62471 Photobiological safety of lamps and lamp systems Voluntary but if you do not follow them,a lot of justification is needed European website where you can find the harmonized standards (based on current MDD): http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/index_en.htm Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 7 Relation with other standards Standalone & embedded Embedded Standalone Health SW Medical Device SW Medical Device SW IEC62304 IEC60601-1 Medical Electrical Equipment IEC82304 Electrical equipment having an Medical Device Medical Electrical Health Software APPLIED PART or transferring energy to Software Equipment – Basic safety or from the PATIENT or detecting such Health SW energy transfer to or from the Any kind of software, which directly or Normative PATIENT and which is intended by its indirectly has an effect on health. Reference MANUFACTURER to be used as a MEDICAL E.g. Radiology Information Systems (RIS), DEVICE Prescription Management Systems (PMS), ISO14971 Laboratory Information Mngt Systems (LIMS) Risk Management ISO13485 IEC62366 Quality Systems Useability Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 8 Out of scope of IEC62304: Validation • Standalone Software: IEC82304 Health Software • Embedded Software: IEC60601-1 Medical Electrical Equipment: Chapter 14: PEMS Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 9 Relation with IEC60601-1 Medical Electrical Equipment Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 10 Content IEC62304 1. Scope 2. Normative references 3. Terms and definitions 4. General Requirements 5. Software Development 6. Software Maintenance 7. Software Risk Management 8. Software Configuration Management 9. Software Problem Resolution 10. Annex A Rationale for the requirements of this standard 11. Annex B Guidance on the provisions of this standard 12. Annex C Relationship to other standards 13. Annex D Implementation Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 11 Product creation in one picture Maintenance feedback & Change Management Field impact on change Installed Base Customer Stakeholder Change Timing, budget Hazards Request product product CM Item Configuration Risk Project / Product Management Management Management (CM) Project Plan Release Product Release Risk V&V Plan Baseline Management Design File Release Notes Reviews Requirements User Manual Problem Reports Control Risk / Benefit Measures analysis V&V Specs V&V Reports Requirements Requirements Verification & Management Specifications Validation (V&V) Peer Regression Reviews Tests Design Specs Peer Design & Software Code Reviews Implementation Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 12 So what is IEC62304 about? Professional Software Development Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 13 Software Classification Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 14 Definition Software classification Class A No injury or damage to health possible Class B Non serious injury possible Class C Death or serious injury possible Dependent on the classification, more requirements from IEC62304 are to be implemented. The idea behind it is that The most unsafe SW requires the most strict SW process Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 15 A B C 5 Software Development 22 46 52 5.1 Development Planning 7 10 11 5.2 Requirements Analysis 5 6 6 5.3 Architectural Design 0 4 5 5.4 Detailed Design 0 1 4 5.5 Software Unit Implementation 1 4 5 5.6 Integration and Testing 0 8 8 5.7 System Testing 5 5 5 Applicable clauses 5.8 Release 4 8 8 6 Software Maintenance 8 8 8 per class 6.1 Establish Software Maintenance Plan 1 1 1 6.2 Problem and Modification Analysis 5 5 5 6.3 Modification Implementation 2 2 2 7 Software Risk Management 1 12 12 7.1 Analysis of software contributing to Hazards 0 5 5 7.2 Risk Control Measures 0 2 2 7.3 Verification of Risk Control Measures 0 2 2 7.4 Risk Management of Software Changes 1 3 3 8 Software Configuration Management 7 7 7 8.1 Configuration Identification 3 3 3 8.2 Configuration Control 4 4 4 8.3 Configuration Status Accounting 1 1 1 9 Software Problem Resolution 8 8 8 Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 16 Differences classification mostly in development • Class A • no architectural design • No detailed design • No unit verification testing • No integration testing • No evaluation of known residual anomalies • Class B • No detailed design Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 17 SW Classification process in the IEC62304 Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 18 Inheritance of safety class SW System C SW Item SW Item SW Unit A B C SW Unit SW Unit SW Unit SW Unit A A B B Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 19 SW Classification process in the IEC62304 • By default the whole SW system is class C • You may use class A only if……(Quote from DEKRA notified body): SW Classification process • Perform the system risk analysis according to ISO14971 • Have the SW architecture defined • Filter out all hazards that have a SW component failure as source • Filter out all hazards that have SW component as control measure • Classify those SW components based on the severity of the hazard • If a HW control measure is defined, the classification can degrade Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 21 Example – surgical robotic system – initial assessment • The system manipulates an instrument inside the organ. The software of the system has full control over this manipulation and can cause serious injuries. Therefore, the software system as a whole is treated as safety class C, with certain subsystems having a lower safety class A. • All complexity and safety-critical aspects are centered in one subsystem. • Application Software subsystem – Class C Includes state control, robotic motion control and a safety layer. The state control controls the states of the system. The robotic motion control controls the manipulation motion of the surgical instrument • Service SW subsystem – Class A • User Interface (GUI) SW subsystem – Class A • Firmware (FW) Software subsystem – Class A Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 22 Example Lung function measuring device – full assessment measure, calculate and present lung function parameters without any diagnosis. NO FORCED EXHALATION IS REQUIRED AS IN SPIROMETRY; PULMONARY FUNCTION VALUES ARE OBTAINED DURING TIDAL BREATHING both the single occlusion technique (SOT) and the interrupter technique (RINT) can be done. In addition, tidal flow volume (TFV) loops can be monitored and analysed Example Lung function measuring device Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 24 Example Lung function measuring device Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 25 Example Lung function measuring device Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 26 Process Vision IEC62304 Medical Device Software – Life Cycle processes Sheet 27 Example Lung function measuring device Process Vision