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.
Medical devicesWe 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.
In-vitro diagnosticsOur 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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