Technical Documentation and Medical Device Regulation
This white paper reviews the regulatory requirements for Technical Documentation under the new MDR, with focus on conformity assessment routes and post-market surveillance. Use this resource as you plan and implement your transition plan for the new Regulation.
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Nanomaterials
This white paper discusses the advent and use of nanomaterials in medical devices and explores the regulatory requirements for devices containing nanomaterials. With increasing focus and scrutiny under the new Regulation, manufacturers should make sure they fully understand the requirements.
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Recent advancements in AI - implications for medical device technology and certification
This white paper provides a very brief overview of where AI is being used in healthcare, and why it might be increasingly seen in medical devices. We also consider what specific additional requirements this might place on regulatory requirements in the near future.
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