Risk Management for Medical Devices (ISO14971:2007)

​DURATION : Two (2) full days
​
​INTRODUCTION
ISO 14971:2007 is the only international standard for risk management for medical devices used to demonstrate compliance with requirements of all regulated markets including the US FDA 21 CFR’s, the EU Directives for Medical Devices (MDD; AIMD; and IVDD), Malaysian Medical Device Act & Regulations, etc. The latest revision to ISO 14971 has also been implemented to address the increased emphasis on risk requirements that have been updated to Medical Device Regulations. This workshop provides a thorough introduction and interpretation of ISO 14971:2007 risk management, throughout the product lifecycle. 

​COURSE OBJECTIVES

1. To understand that risk analysis is a regulatory requirement for all classes of medical device 
2. To understand risk management versus risk analysis 
3. To understand the interaction with ISO 13425:2003
4. To address fundamental differences between ISO 14971:2007 and EN ISO 14971:2012
5. To be able to plan ISO 14971 strategy appropriate to scope & responsibilities of Legal Manufacturer –v- Contract Manufacturer
6. To be able to construct a basic risk management plan 
7. Use of the ISO 14971:2007 annexes in conducting a risk analysis 
8. Identification of key quality management system procedures which need to link to risk management
9. Recognition that FMEA (Failure Mode and Effects Analysis) alone is not medical device risk analysis
10. The requirements and structure of a Risk Management File

COURSE OUTLINE

1. Regulatory requirements for medical device risk management 
2. Content and interpretation of ISO 14971:2007 
3. Alignment of ISO 14971:2007 to ISO 13485:2003
4. What is a risk management plan?
5. How to conduct a risk analysis
6. What is risk control?
7. Requirements for a Risk to Benefit evaluation
8. The risk management process within the product lifecycle 

TARGET AUDIENCE

• Quality Managers 
• Regulatory Affairs Managers 
• Auditors of Medical Device manufacturing firms (internal and external) 
• Cross functional team members of implementation project
• Risk Management Team members ​

PRE-REQUISITES
Basic understanding of the Medical Devices Regulations, ISO 13485 2003 and basic understanding of Design and Development Control is preferred. Previous knowledge of ISO 14971:2007 not required.​

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