Changing regulations require legal manufacturers of medical devices, combination products, and in-vitro diagnostics to comply with MDR and IVDR before placing respective products on the market.
We provide support on demarcation issues (medical devices – food – drug), check of regulatory requirements, carrying out of consultation procedures for medical devices containing pharmacological substances, and correspondence with Notifies Bodies. As experts in substance-based medical devices, we are specialized in the coordination and conduction of necessary studies and in compiling all elements of Technical Documentations.
Our support ranges from product design and development, manufacturing, testing, and regulatory expertise. We also offer CE certification services for IVD medical devices under the IVDR.
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