Life cycle of medical devices: regulations in a worldwide market
Lifecycle management in the medical device industry is constantly evolving because of new legal regulations; the complex risks associated with modern technology; the more advanced levels of oversight for legacy products; and increased exposure of development cycle process gaps. Consequently, the timelines for conformity assessments of quality system and technical documentation have also increased. This directly challenges organizations to develop more proactive lifecycle strategies when preparing to obtain their CE mark, the formal sign of conformity received from a notified body indicating that the device has met both quality system and technical documentation requirements of the EU Medical Device Regulation and can be placed in the EU market. Implementing a full regulatory programme can be very expensive and demanding on resources. With the rapid growth in the global market for medical devices, there is a need to harmonize national standards in order to minimize regulatory barriers, facilitate trade and improve access to new technologies. Harmonization also reduces the cost of implementing regulations for governments and local industry. This lesson will provide a comprehensive overview of the life cycle management of medical device taking into account the different regulation approaches in a worldwide market.
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