Effective Risk Management For Medical Devices Webinar

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Webinar held 1 February 2011

Effective Risk Management For Medical Devices Webinar

  1. 1. A MedTech Consulting Company for Regulatory, Reimbursement & Business Development SolutionsEffective Risk Managementfor Medical devicesby Mats Petersson, Synergus SW for Medical Devicesmats.petersson@synergus.comwww.synergus.com Robert.Ginsberg@synergus.seWebinar 1 February 20111
  2. 2. Introduction of the speaker Mats Petersson 15 years in Medical Device Development Main focus on Risk Management and QS Participated in many audits, FDA, MDD etc.2
  3. 3. Synergus’ One World-One Team 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 Network3
  4. 4. Synergus MedTech Core Competence 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 Assurance4
  5. 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.com5
  6. 6. The Big Picture for Risk managementin a Medical Device regarding MDD ISO 13485 IEC 62366 ISO 14971 Risk MDD Manage- (AIMD) ISO 10993 (IVDD) ment IEC 60601-1 Device etcetera6
  7. 7. 14971 calls for RM activities throughthe whole device lifecycle Planning Development Release Maintenance Risk Management7
  8. 8. RM engineers have to find efficient implementation of 149718
  9. 9. It is challenging to find a proper level of effort for RM Productivity Compliance9
  10. 10. Risk management can support effective and safe development10
  11. 11. Freedom from unacceptable risk Define ”Intended use statement” Define risk levels for the use of your product11
  12. 12. Use risk management to plan yourefforts when developing the product Death • Thorough QA • Additional Minor injury QA activities Safe • Basic QA12
  13. 13. Governments and Agencies are 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, 6230413
  14. 14. The Bar is Raised Over Time Accident New laws People get and hurt or die regulations Public reaction14
  15. 15. The authorities are introducingnew standards and guidelinesExample:IEC 60601-2-32:MEDICAL ELECTRICALEQUIPMENT PART 2:PARTICULARREQUIREMENTS FORTHE SAFETY OFASSOCIATEDEQUIPMENT OF X-RAYEQUIPMENT15
  16. 16. Quality assurance techniques have a long history in the industry16
  17. 17. Plan your risk management• This is beneficial aswell as required to do.• Synchronize withdevelopment plans.• Decide your output.• Adjust the planwhen you have moreinformation.17
  18. 18. There are more and more Medical Device areas that require Risk mgmt Bio- Human compa- factors tibility Animal tissue Medical Device guidelines / standards18
  19. 19. There is a number of techniques available for Risk Management FTA Risk PHA manage- HAZOP ment FMECA19
  20. 20. Perform early analysis using PHA with available information Intended use System Experience PHA Use Check- environment lists20
  21. 21. HAZOP Methodology use guide words to analyze hazards in a systematic way Guide Word Deviation Para- meter21
  22. 22. Fault Tree Analysis is a top down technique useful at early stages Top Level Event Faults /Low Level Event Causes Root Cause Mitigator22
  23. 23. FMECA is a bottom 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 defined23
  24. 24. Items and units are the building blocks of a system Unit Unit Unit Unit Item X Item Y OEM unit Item Z System24
  25. 25. Each manufacturer needs to find his own mix of techniques for Risk Mgmt HAZOP FTA FMECA Effective risk management process25
  26. 26. ISO 14971 requires a 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 riskRisk management report • Freedom from unacceptable risk (Post-) Production • E.g: Risk analysis of customer complaints26
  27. 27. Risk Control Measures are 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 appropriate27
  28. 28. Defining a safe architecture is one ofthe major tasks Safe architecture • Proper partitioning • Redundant functionality • Testable • Predictable behavior • ”Flight recorder” – On lab – In field28
  29. 29. Example on how Risk 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. 30. A key message in 14971 is to do design for safety if possible Safe design Protective measures in device Protective measures in process Information30
  31. 31. Verification confirms that risk 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. 32. Risk management can be time consuming and hard32
  33. 33. A risk based development can utilize the resources efficiently33
  34. 34. Safe products are the result of a well working process Quality Manage- ment Risk Mana- gement Develop- ment and production34
  35. 35. Building a solid process 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-tools35
  36. 36. Courses during 2011:Risk Management for Medical Devices 3 . March London Please see www.synergus.com for our complete course program36
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