Medical Device Product Life-Cycle

This module is designed to give learners an understanding of the life cycle of a medical device and where sterility assurance provides input into medical device lifecycles.  It will provide learners with the information and skills to enable them to have a thorough understanding of the design and development of medical devices from concept to commercialisation.  It will also enable learners to have fundamental understanding of pre and post -marketing authorisation requirements for medical devices. The leaner will thus be able to participate effectively as part of sterility assurance teams in the medical devices and healthcare industries. Learners will have gained sufficient knowledge of the lifecycle of medical devices and healthcare products to enable them to take up responsible positions in sterility assurance within Industry.

1. Critically review the medical device life cycle from design & development, design verification and validation and post market activities as they apply to sterility assurance.

2. Compare and contrast the regulatory submission activities for the US and Europe and other key global markets and become a competent business partner to the regulatory affairs department and be capable of preparing for regulatory submissions and addressing questions.

3. Demonstrate detailed knowledge and systematic understanding of packaging validation requirements for medical devices.

4. Evaluate and show a detailed knowledge of the reprocessing requirements for medical devices.

5. Demonstrate a clear understanding on how supplier management chain functions in a medical device manufacturing environment and be a competent business partner to the supplier management and procurement teams.