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Welcome to the MDM West Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

How to Design an Easy to Maintain Risk Management System

Mark Rutkiewicz  (VP Quality, Innovize)

Location: 210D

Date: Tuesday, February 11

Time: 2:05pm - 3:00pm

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