AF

Alan G. Fraser

14 records found

Background and purpose — Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published on national Ministries of Hea ...
Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of ...

Improved clinical investigation and evaluation of high-risk medical devices

The rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing ...

Improved clinical investigation and evaluation of high-risk medical devices

The rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing ...