Resources
The frameworks that guide our work.
A concise reference to the core regulations and standards we apply across every medical device programme. Detailed insight articles are published here as they are released.
Biological Evaluation of Medical Devices
The framework for evaluating the biocompatibility of medical devices, including planning (10993-1), chemical characterization (10993-18) and toxicological risk assessment (10993-17).
Application of Risk Management
The international standard for applying risk management to medical devices across the product lifecycle.
Quality Management Systems
Requirements for a quality management system for organisations involved in the medical device lifecycle.
EU Medical Device Regulation
The regulation governing the placing of medical devices on the European Union market, including technical documentation and clinical evaluation requirements.
US FDA Device Regulation
US regulatory framework covering device classification and premarket pathways such as 510(k), De Novo and PMA.
Medical Device Single Audit Program
A single regulatory audit of a manufacturer's QMS that satisfies the requirements of multiple participating regulatory authorities.
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