Left to Our Own Devices: Design Control and Risk Management Strategies for Combination Products

09:50 - 10:25


  • Design controls are a relatively new regulatory requirement for the development of drug/device combination products.
  • Manufacturers are now expected to establish and maintain Design History Files throughout the lifecycle of such products.
  • The requirements associated with medical device risk management activities are also expected to be followed as part of combination product development and lifecycle management.
  • Subtle differences exist between the approaches to medical device and drug product risk management; however, the two can be reconciled without either being compromised.

Richard Wedge, Compliance Lead , Pfizer Ltd