nexialist Information

Nexialist is a consulting firm specializing in regulatory intelligence and compliance of healthcare products In the healthcare 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_