Nexialist is a consulting firm specializing in regulatory intelligence and compliance of healthcare products In the healthcar ... e field, regulations are constantly being tightened and their application has become the number one challenge for company managers! In this context, being accompanied by nexialist is to ensure, thanks to a multidisciplinary team of experts and proven working methods : . to deal with regulatory affairs in complete serenity, by anticipating regulatory changes, . to increase the competence of internal teams through adapted training programs, . accelerate the access of products to the market and maintain them over time . to control its technical documentation gathering the proofs of conformity . to implement a quality system that complies with organizational requirements . transform regulatory requirements into business opportunities and thus reintegrate regulations into the heart of the company's strategy Our areas of expertise : Regulatory strategy. QMS. Product compliance and STED technical file. Internal/external audits. Training. Electrical safety. CE Marking. Emergency missions. Design and development. Regulatory and normative watch. Process validation . Clinical evaluation . Post market surveillance . Optimization of the marketing. Support for international development. Our clients : Manufacturers, distributors, and subcontractors: medical devices / in vitro diagnostics / innovative therapies Medtechs and Biotechs Competitiveness clusters, Notified Bodies, Research centers www.nexialist.fr and also follow us on Twitter : @Nexialist_ read more