QUOTED. 26 February 2021. Teresa Perry.
Executive Summary
Many elements need to be considered when notified bodies are deciding whether to undertake virtual audits in the context of the new EU medtech regulations. Teresa Perry of BSI Netherlands discussed some of the factors in play.
“We must do everything in our power to get on site and not unnecessarily extend our remote audit practices. This requires a case-by-case risk review, not going further than is necessary to ensure continuous availability of safe and performant devices to patients.” – Teresa Perry, global quality and accreditation manager for BSI Regulatory Services (Medical Devices), BSI Netherlands
- Find out more: When Will A Notified Body Conduct An MDR/IVDR Virtual Audit And How? BSI Netherlands Gives Its Views
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