Mitigating Risk of Shortages: More Time to Certify Medical Devices – European Commission
The European Commission has recently approved a proposal to extend the time it takes to certify medical devices in order to reduce the risk of
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Robotic Orthopaedic Surgery: Latest Trends
Human beings are living longer and healthier lives than ever, however sometimes this longevity requires assistance. In recent years, there has been a surge in
Notice to Manufacturers: MDR Requirements
MDCG Position Paper Notice to manufacturers to ensure timelycompliance with MDR requirements In April 2022, 75% of notified bodies indicated that more than 50% of
Medical Devices Regulation Updates
Medical Devices Regulation Medical Device Regulation (MDR) & In-Vitro Diagnostic Devices Regulation (IVDR) The EU’s Medical Device Regulation (MDR) 2017/745 and Regulation 2017/746 on In-Vitro
New Sterilisation Methods
New sterilisation methods are being developed to address concerns by the EPA and FDA surrounding EtO sterilization. De Lama has developed its HyPerPure® technology, which
Medical Device Regulation (MDR) guidance update
The European Commission’s Medical Device Coordination Group (MDCG) has updated Medical Device Regulation (MDR) guidance aimed at manufacturers and notified bodies that work with implantable
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