Is your Essential Requirements Checklist (ERC) up to snuff?

Instructor: Cheryl Wagoner
Product ID: 703384
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Training CD

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Read Frequently Asked Questions

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.

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Having an out of date or non-compliant Essential Requirements Checklist (ERC) can prolong review of technical files.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

Instructor Profile:

Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.

Cheryl is a member of Regulatory Affairs Professionals (RAPS), Association for the Advancement of Medical Instrumentation (AAMI), Medical Device Manufacturers (MDMA) FDA Working Group, and the MDMA Compliance Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management.

Topic Background:

Annex I of 93/42/EEC: EU Medical Device Directive (MDD) is entitled “Essential Requirements”. Demonstration of compliance with the Essential Requirements is typically done through an Essential Requirements Checklist or ERC. In 2012, the European Commission proposed a new EU Medical Device Regulation that revised the Essential Requirements from 13 to 19 ERs. Notified Bodies place much emphasis on the ERC. It provides them with an overview and pointer document during their review of product technical files.

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