Achieving Compliance Through the Adequate Evaluation of Risk

Thu. November 1| 9:15 AM - 10:00 AM | 211A

Conference: MD&M Minneapolis 2018

Track: MD&M Track A: R&D & Product Development

Format: 45-Minute

Pass Type: Conference Pass (Paid)

Risk management is an integral part of the medical device product lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators or the environment and shows continued confidence that risk is acceptable after product commercialization. The main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product.

Topics covered include:
  • Defining your risk management framework
  • Appropriate design input and design output documentation
  • Designing your risk management files for maintainability after product launch


Rob Zenk

Rob Zenk

Manager, Risk Management


Role: Speaker