This webinar will focus on the new requirements of EU Medical Device Directive Essential Requirements Checklist (ERC). It will also explain the relationship between ERC, Clinical Evaluation Report and Technical File.
This webinar will explain the overall ERC with emphasis on the 6 new requirements.
Why Should You Attend:
Having an out of date or non-compliant Essential Requirements Checklist (ERC) can prolong review of technical files. It can also result in observations during ISO audits. Keeping your ERC “up to snuff” can help you avoid costly delays in getting to market and may also help you avoid certain audit observations.This webinar will explain the overall ERC with emphasis on the 6 new requirements.
Areas Covered in the Webinar:
- Background of the ERC and the proposed changes
- Define Essential Requirements and their relationship to Essential Requirements Checklist
- Format of an ERC
- Sections to be addressed in the ERC
- What has changed in the 2012 proposal? How can you meet the new requirements?
- Relationship between ERC, Clinical Evaluation Report, and Technical File
- Resources
Who Will Benefit:
- Regulatory/Quality Managers or Project Managers
- Regulatory/Quality Specialists who Compile European Technical Files
- Clinical Personnel who Contribute to European Technical Files
- Product Development Managers or Project Managers
Course Provider
Cheryl Wagoner,
