Consultancy

ConsulTeam Medical, with its expert staff provides consultancy services to medical device manufacturers and the distributors for quality management systems and product certification. These consultancy services covers mainly design and development, software validation, product testing, regulatory requirement compliance, risk management, process optimization.

Our consultants will be happy to assist you with their detailed knowledge about ISO 13485, MDR, IVDR , EU Medical Device Directives (93/42 / EEC, 90/385 / EEC, 98/79 / EC) and FDA-510, (K). For detailed information about the regulatory requirements of the country where you intend to launch your product please feel free to contact our staff at bizesorun@13485.info