In the beginning, Dr. Albert Tsang (past-chairman – HKSQ) introduced two speakers for the seminar. Mr. Marvin Lee is the Product Manager in Systems & Services Certification, SGS and he is also the member of Quality and Regulatory Affairs Panel in Hong Kong Medical and Healthcare Device Industries Association (HKMHDIA). Mr. Sam Wong is the Assistant General Manager in Vincent Medical Mfg. Co., Ltd.
Marvin gave the first talk entitled “ISO 14971 Application of Risk Management to Medical Devices – Introduction”. He showed the global requirements on risk management application including The FDA Quality Systems Regulation (USA), 93/42/EEC Annex I (EU), Canadian Medical Device Regulation 1998 (Canada), MHLW Ministerial Ordinance No.169, 2004 (Japan), etc.
Global Harmonization Task Force (GHTF) has encouraged members to use SG3/N15R8/2005 – Implementation of Risk Management Principles and Activities within a Quality Management System (http://www.ghtf.org/). Even though ISO 13485:2003 did not require to use ISO 14971 risk management standard mandatory, ISO 14971 is still broadly accepted and used as risk management system in medical device industries.
The history of risk management standard development for medical device was shown as follows:
- EN 1441:1997 Medical Devices Risk Analysis
- ISO 14971:2000 (1st edition) on 3 Dec 2000
- ISO 14971:2000/Amd.1:2003 (amendment) on 28 Feb 2003
- ISO 14971:2007 (2nd edition) on 1 March 2007
The diagram showed the risk management process.
There are three critical documents required for risk management, namely Risk Management File (RMF), Risk Management Plan (RMP) and Risk Management Report (RMR).
RMF consists of quality records to document the results of all risk management activities. Generally, it includes the background information and references to support the decision during risk analysis.
RMP consists of the scope of the plan (which identified the device and its lifetime), who is responsible to, risk acceptability criteria design and verification plan, as well as, post-production information collection.
RMR should be issued before design or manufacture and it provides traceability from each hazard to risk control measures. Overall residual risk is recorded in the report and demonstrates the product is safe for its intended use.
Lastly, Marvin also briefed the 15 steps to ISO 14971. They are
1. Risk management plan establishment
2. Intended use / purpose and identification of characteristics related to the medical device safety
3. Identification of known or foreseeable hazards
4. Estimation risk in each hazard
5. Risk evaluation
6. Risk reduction
7. Option analysis
8. Implementation of risk control measures
9. Residual risk evaluation
10. Risk/benefit analysis
11. Risk arising from risk control measures
12. completeness of risk evaluation
13. Overall residual risk evaluation
14. Risk management report
15. Post-production information.
He analyzed four difficulties and obstacles during the implementation as follows:
i) Understanding of ISO 14971
Sam said they need a consultant to coach the whole project.
ii) Technical Knowledge Acquisition
Technical training for staff is also needed.
iii) Resources
Resources need including Human, Money and Time Investment.
iv) Maintenance
It needs top management commitment to maintain the long run program.
He lastly summarized some advantages after implemented ISO 14971.
i) Less risk from product on end-user
ii) More consideration during product design and manufacturing
iii) Less lost come from product safety (such as product recall)
iv) Increase customer confidence
v) Reduce the difficulty on product registration
The last session was “Introduction to CE Mark Certification”. Marvin introduced the CE marking which is a “Passport” of products to market in European Union (EU). The EC Directives related to Medical devices as follows:
93/42/EEC Medical devices
98/79/EEC In vitro diagnostic medical devices
90/385/EEC Active implant able medical devices
The follow table showed the classification of medical devices.
The souvenir presented to Mr. Sam Wong
Group photo
Related activities:
Visit two Mainland Medical Devices Manufacturers
Useful linkage for product recall
Hong Kong – Medical Device Control Office
http://www.mdco.gov.hk/tc_chi/press/press.html
http://www.mdco.gov.hk/tc_chi/recalls/recalls.html
USA – FDA – CDRH
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm
Australia – TGA
http://www.tga.gov.au/recalls/index.htm
Canada – Health Canada
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/index_e.html
- EN 1441:1997 Medical Devices Risk Analysis
- ISO 14971:2000 (1st edition) on 3 Dec 2000
- ISO 14971:2000/Amd.1:2003 (amendment) on 28 Feb 2003
- ISO 14971:2007 (2nd edition) on 1 March 2007
The diagram showed the risk management process.
There are three critical documents required for risk management, namely Risk Management File (RMF), Risk Management Plan (RMP) and Risk Management Report (RMR).
RMF consists of quality records to document the results of all risk management activities. Generally, it includes the background information and references to support the decision during risk analysis.
RMP consists of the scope of the plan (which identified the device and its lifetime), who is responsible to, risk acceptability criteria design and verification plan, as well as, post-production information collection.
RMR should be issued before design or manufacture and it provides traceability from each hazard to risk control measures. Overall residual risk is recorded in the report and demonstrates the product is safe for its intended use.
Lastly, Marvin also briefed the 15 steps to ISO 14971. They are
1. Risk management plan establishment
2. Intended use / purpose and identification of characteristics related to the medical device safety
3. Identification of known or foreseeable hazards
4. Estimation risk in each hazard
5. Risk evaluation
6. Risk reduction
7. Option analysis
8. Implementation of risk control measures
9. Residual risk evaluation
10. Risk/benefit analysis
11. Risk arising from risk control measures
12. completeness of risk evaluation
13. Overall residual risk evaluation
14. Risk management report
15. Post-production information.
Sam shared his experience in the implementation of ISO 14971 in Vincent Medical Mfg. Co., Ltd. He explained the reasons of his company to seek the risk management standard certification. It was because the certification could strengthen the product design safety by using advance systematic approach and considering more technical aspects during the design. Moreover, it was also the market trend for customer satisfaction and demonstrated the company commitment on product safety. It not only enhances product quality awareness and inter-department communication, but also communication with customer.
He analyzed four difficulties and obstacles during the implementation as follows:
i) Understanding of ISO 14971
Sam said they need a consultant to coach the whole project.
ii) Technical Knowledge Acquisition
Technical training for staff is also needed.
iii) Resources
Resources need including Human, Money and Time Investment.
iv) Maintenance
It needs top management commitment to maintain the long run program.
He lastly summarized some advantages after implemented ISO 14971.
i) Less risk from product on end-user
ii) More consideration during product design and manufacturing
iii) Less lost come from product safety (such as product recall)
iv) Increase customer confidence
v) Reduce the difficulty on product registration
The last session was “Introduction to CE Mark Certification”. Marvin introduced the CE marking which is a “Passport” of products to market in European Union (EU). The EC Directives related to Medical devices as follows:
93/42/EEC Medical devices
98/79/EEC In vitro diagnostic medical devices
90/385/EEC Active implant able medical devices
The follow table showed the classification of medical devices.
The souvenir presented to Mr. Marvin Lee
The souvenir presented to Mr. Sam Wong
Group photo
Related activities:
Visit two Mainland Medical Devices Manufacturers
Useful linkage for product recall
Hong Kong – Medical Device Control Office
http://www.mdco.gov.hk/tc_chi/press/press.html
http://www.mdco.gov.hk/tc_chi/recalls/recalls.html
USA – FDA – CDRH
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm
Australia – TGA
http://www.tga.gov.au/recalls/index.htm
Canada – Health Canada
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/index_e.html
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