News
Keep up to date with AQF Medical
More Time to Certify Medical Devices
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 shortages.
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Robotic Orthopaedic Surgery
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 robotic-assisted orthopaedic surgery.
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MDCG Position Paper
Notice to manufacturers to ensure timely compliance with MDR requirements. In April 2022, 75% of notified bodies indicated that more than 50% of applications were incomplete.
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Medical Devices Regulation Updates
The EU's Medical Device Regulation (MDR) 2017/745 and Regulation 2017/746 on In-Vitro Diagnostic Devices continue to evolve as compliance deadlines approach.
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New Sterilisation Methods
New sterilisation methods are being developed to address concerns by the EPA and FDA surrounding EtO sterilization, including De Lama's HyPerPure technology.
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Medical Device Regulation (MDR) Guidance Update
The European Commission's Medical Device Coordination Group (MDCG) has updated MDR guidance aimed at manufacturers and notified bodies that work with implantable devices.
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AQF Medical
Mullaghboy Industrial Estate, Athboy Road, Navan, Co. Meath, Ireland
AQF Asia
17 Senoko Loop, Woodlands East Industrial Estate, Singapore