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We are an independent firm of medical device regulatory affairs specialists. Our expertise in the medical device regulatory and quality field is based on the wide ranging experience of our people. We know the importance of teamwork, and we are proud of the network of regulatory professionals we have established over many years. Our scope of application includes a truly global array of medical device regulatory frameworks ranging from the outgoing Medical devices directives, the relatively new EU Medical Device Regulation 2017_745, the United Kingdom’s UK MDR 2002 (as amended), as well as those of North, and South America, such as the Brazilian ANVISA regulatory framework, and further afield.

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