Regulatory consultancy services for medical devices, in vitro diagnostics, software as a medical device (SaMD), and AI-based medical technologies. Supports CE marking and FDA approval pathways, quality system implementation, and clinical testing compliance with MDR 2017/745, IVDR 2017/746, and 21 CF...
Manufactured by
CMG MEDDEV SL
Torrecaballeros, Spain
At CMG MedDev , we specialize in providing regulatory consulting services for medical devices MD, in vitro diagnostics IVD, software MDSW and MDAI and AI-based technologies. This consultancy is aimed at ensuring the safety and functionality of the products, complying with the legal requirements (MDR2017/745, IVDR 2017/746, 21 CFR 820, 21 CFR 11) and the reference standards and guides, to obtain the CE marking of the same or FDA approval . We are also specialized in providing services to diagnostic and testing laboratories. The Quality Systems of these laboratories are key both in applying ISO 15189 and ISO 17025, either for in-house products, or for biocompatibility testing and being able to be part of the ASCA system, or for any other product testing that needs to be accredited to be recognized as valid in the healthcare and pharmaceutical sectors. We provide organizations with the confidence and security needed to operate in a highly regulated environment.
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