- 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