Documentation for IEC 60601-1 3rd Edition Compliance
Overview:
In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition.
The purpose will be to provide medical device manufacturers with information on how to provide certification bodies with the information they need to certify products to the Third Edition in the most efficient manner. By preparing in advance for certification reviews and testing, the product should move through the process quickly and efficiently. We will especially look at the risk management documentation requirements and how to provide the information requested.
Why you should attend: In 2012, IEC 60601-1 3rd Edition will be the requirement for product certification in Europe and Canada. In 2012, the US will join these countries in full recognition of the 3rd Edition and withdrawal of recognition of the 2nd Edition. Even now, test houses are reporting delays in moving products through the certification process for the 3rd Edition. The addition of the requirements for risk management and the collateral standards have added cost to the certification process as well as additional time requirements.
Areas Covered in the Session:
- Requirements of IEC 60601-1 Third Edition
- Required use of Collateral standards
- Required use of Particular standards
- Required use of ISO 14971 Risk Management
- Use of IECEE Test Report Forms
Who will benefit:
- Compliance Engineers
- Project Managers
- Quality Engineers
- Regulatory Managers
- Design Engineers
- Design Managers