Cooperation with us ensures compliance for your company
Whether we provide validation, project management, management consulting or training, we always make sure to prepare you with the most precise legislative interpretations, enabling you to generate and maintain sustained competitive advantage. Cooperation with us enables you to always deliver the highest quality and to always ensure that you are in compliance. Plan your company’s success in collaboration with us.
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We have a broad range of specialist-trained consultants, which we hand-pick for your specific needs
New EU rules on safety requirements and testing of medical devices
From 26 May 2021, new EU requirements apply to e.g. safety and testing of medical devices. The date marks the deadline for meeting the new EU Medical Device Regulation (MDR), which i.a. sets stricter requirements for new medical devices to be biologically safe to use for patients and users.
Requirements for medical equipment - ISO 10993
All medical equipment must per. May 26, 2021 meet the requirements of the new EU Medical Device Regulation (MDR). The stricter requirements mean, among other things, that the biocompatibility of the new equipment must be investigated.
Medical device manufacturers are responsible for ensuring that patients and users are exposed to a minimal health risk when using the equipment. Manufacturers must i.a. know exactly what chemical substances the equipment may leak during use.
Risk assessment of medical devices
As part of the new EU Medical Device Regulation (MDR), EU manufacturers of medical devices must comply with the requirements of general safety and performance requirements. What is called General Safety & Performance, in everyday speech GSPR. It is an updated version of the previous Essential Requirements (ESS) in the current Medical Device Directive (MDD). The requirements are part of the technical documentation for a medical device.
