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How to Design an Easy to Maintain Risk Management System

Mark Rutkiewicz  (VP Quality, Innovize)

Location: 210D

Date: Tuesday, February 11

Time: 2:05 pm - 3:00 pm

Track: MD&M Conference: Keeping Up & Staying Compliant with Global & FDA Regulations

Vault Recording: TBD

The new EU MDRs require maintaining your product's Clinical Evaluation Reports (CER) and a key aspect is maintaining your product risk assessments with new information from your complaint system. In this session, you’ll hear about best practices for an easy to use and maintain information infrastructure that helps you align R&D, design, regulatory and quality initiatives.

Topics covered include:

  • Breaking down preconceived notions on implementing the requirements of applicable laws, regulations, guidance, standards, and internal policies
  • How to make product information easily accessible to Engineers, while maintaining patient privacy
  • Eliminating duplicate processes for compliance with various regulatory and quality standards