Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
HeartStitch Wins CE Mark Approval for Mitral Valve Repair Device
The device uses sutures to repair the valve to prevent mitral regurgitation.
FDA Advisory Committee Recommends Approval for Cannabis Derived Treatment for Epilepsy
The candidate’s PDUFA goal date is June 27, but an FDA representative said the agency is working to expedite the review.
Medical Devices
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