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Effective Risk Management For Medical Devices Webinar
- 1. A MedTech ConsultingCompany for Regulatory, Reimbursement & Business Development Solutions Effective Risk Management for Medical devices by Mats Petersson, Synergus SW for Medical Devices mats.petersson@synergus.com www.synergus.com Robert.Ginsberg@synergus.se Webinar 1 February 2011 1
- 2. Introduction of thespeaker Mats Petersson 15 years in Medical Device Development Main focus on Risk Management and QS Participated in many audits, FDA, MDD etc. 2
- 3. Synergus’ One World-OneTeam Philosophy NO SWE FIN NL CAN UK DE FR JPN PO USA S.KOR ES PRC CH MEX IT BE IND COLUMBIA AT BRA VEN ARG SA AUS CHILE Synergus Unity in Diversity: 13 Nationalities Synergus Projects Market competence & 16 Languages Office/Core Alliances KOL Network 3
- 4. Synergus MedTech CoreCompetence Portfolio Regulatory, Reimbursement, and Global MedTech Conferences Market Access Hands-on Strategy Educating Leaders Consulting, Implementation and Thought Leadership Monitoring Services SYNERGUS Core Competence Extensive in-house knowledge base in clinical areas: Management Services Cardiovascular Orthopedics Change Management Sleep Medicine IVDs QA/RA Interim Management Oncology Neurology Project Management Design Control Software Software Quality Assurance 4
- 5. Before we start… • There will be time for questions after the presentation • You can use the chat function to write your questions to me • More complicated issues, please use the email and I will try to answer directly if possible: – mats.petersson@synergus.com 5
- 6. The Big Picturefor Risk management in a Medical Device regarding MDD ISO 13485 IEC 62366 ISO 14971 Risk MDD Manage- (AIMD) ISO 10993 (IVDD) ment IEC 60601-1 Device etcetera 6
- 7. 14971 calls forRM activities through the whole device lifecycle Planning Development Release Maintenance Risk Management 7
- 8. RM engineers haveto find efficient implementation of 14971 8
- 9. It is challengingto find a proper level of effort for RM Productivity Compliance 9
- 10. Risk management cansupport effective and safe development 10
- 11. Freedom from unacceptablerisk Define ”Intended use statement” Define risk levels for the use of your product 11
- 12. Use risk managementto plan your efforts when developing the product Death • Thorough QA • Additional Minor injury QA activities Safe • Basic QA 12
- 13. Governments and Agenciesare enforcing new regulation across time EU-Commission/US Government MDD/Public Health Service Act Agencies Medical Products Agency/FDA Laws and Regulations SFS 1993:584/21 CFR 820 Guidance docs Standards – 13485, 14971, 62304 13
- 14. The Bar isRaised Over Time Accident New laws People get and hurt or die regulations Public reaction 14
- 15. The authorities areintroducing new standards and guidelines Example: IEC 60601-2-32: MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT 15
- 16. Quality assurance techniques have a long history in the industry 16
- 17. Plan your riskmanagement • This is beneficial as well as required to do. • Synchronize with development plans. • Decide your output. • Adjust the plan when you have more information. 17
- 18. There are moreand more Medical Device areas that require Risk mgmt Bio- Human compa- factors tibility Animal tissue Medical Device guidelines / standards 18
- 19. There is anumber of techniques available for Risk Management FTA Risk PHA manage- HAZOP ment FMECA 19
- 20. Perform early analysisusing PHA with available information Intended use System Experience PHA Use Check- environment lists 20
- 21. HAZOP Methodology useguide words to analyze hazards in a systematic way Guide Word Deviation Para- meter 21
- 22. Fault Tree Analysisis a top down technique useful at early stages Top Level Event Faults /Low Level Event Causes Root Cause Mitigator 22
- 23. FMECA is abottom up technique to find failure modes of components/items • Bottom up • Risk ranking ( probability * severity ) • Can become very detailed and cumbersome • From the beginning oriented to HW • Can be introduced when Items are defined 23
- 24. Items and unitsare the building blocks of a system Unit Unit Unit Unit Item X Item Y OEM unit Item Z System 24
- 25. Each manufacturer needsto find his own mix of techniques for Risk Mgmt HAZOP FTA FMECA Effective risk management process 25
- 26. ISO 14971 requiresa life cycle approach to risk management • Identification of Intended use Risk analysis • Identification of Hazards, FTA and FMECA • Estimation of Risk(s) • Acceptable risks Risk evaluation • Not acceptable risks • Option analysis • Implementation of risk control measures Risk control • Risk/benefit analysis • Risks from risk control measures • Completeness of risk control Residual risk • Analysis of overall residual risk Risk management report • Freedom from unacceptable risk (Post-) Production • E.g: Risk analysis of customer complaints 26
- 27. Risk Control Measuresare expected to be expressed as requirements • Evaluation of new risks due to implementation of RCMs • Re-evaluation of RM file when appropriate regarding changes in requirements • Update of system requirements when appropriate 27
- 28. Defining a safearchitecture is one of the major tasks Safe architecture • Proper partitioning • Redundant functionality • Testable • Predictable behavior • ”Flight recorder” – On lab – In field 28
- 29. Example on howRisk Analysis acti- vities can relate to key documents Customer reqs Sys arch & SW reqs SW arch PHA (checklist) System RA (FTA) SW RA (FMECA) 29
- 30. A key messagein 14971 is to do design for safety if possible Safe design Protective measures in device Protective measures in process Information 30
- 31. Verification confirms thatrisk control is effective Intended use Requirements Verifiaction and Validation • Risk analysis • Design • Are the risk (will be implementation control performed with (risk control measures different measures will implemented? methods at be implemented • Are the risk different as control stages) requirements) measures effective? 31
- 32. Risk management canbe time consuming and hard 32
- 33. A risk baseddevelopment can utilize the resources efficiently 33
- 34. Safe products arethe result of a well working process Quality Manage- ment Risk Mana- gement Develop- ment and production 34
- 35. Building a solidprocess can enable productivity Synergus can contribute with consulting within: • Auditing and reviews • Mentoring • Risk manager role • QA role (Quality Assurance) • Process development and documentation • Product documentation • Implementation of supporting IT-tools 35
- 36. Courses during 2011: RiskManagement for Medical Devices 3 . March London Please see www.synergus.com for our complete course program 36
- 37.