This presentation will examine the requirements of IEC 60601-1 for use of ISO 14971 risk management and interpret those requirements. In addition, there will be practical examples of application and documentation of risk management activities in a manner that meets IEC 60601-1 and ISO 14971 requirements.
Why Should You Attend:The new edition of IEC 60601-1 requires the use of the medical device risk management standard ISO 14971 to meet IEC 60601-1 requirements. This philosophy is new to the medical device industry and companies are struggling with interpreting this new requirement.
Areas Covered in the Session: - Documentation requirements of IEC 60601-1
- Documentation requirements of ISO 14971
- Use of Risk Management with Collateral and Particular IEC 60601 standards
- Documenting hazards and hazardous situations from IEC 60601-1 family
- Examples of documentation practices to meet requirements of both standards
