9 Key Changes Introduced by the EU Medical Device Regulation (MDR) 2017/745

The medical device sector is highly regulated due to the risk to patient safety, including serious illness or death, which is posed by defective medical devices and/or devices that do not perform as intended. In Europe, medical devices are regulated by the Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) …

Author Breda Kearney

Quality Director

6 Key Considerations for Planning a Remote Audit

COVID19 has changed the way we work, with the majority of people now working from home due to travel restrictions and social distancing requirements. In the world of ISO auditing, one of the biggest changes has been the move from predominantly “On-Site” to “Remote” based audits (Auditor and Auditee are in different physical locations). Remote …

Author Breda Kearney

Quality Director

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