Devices at the border of definitions:
Conformity assessment through self-declaration.
Conformity assessment performed by conformity assessment body:
Conformity assessment of medical devices through the recognition of EU certificates:
Declaration of conformity.
Conducting of surveillance audits for issued certificates.
Nikolay Matlaev, The lead auditor on certification of quality management systems and conformity assessment with technical regulations of the Ukrainian Scientific Institute of Certification
PROGRAM Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies: medical devices supplied with a medicinal product medical devices for drug delivery products that are integral with the medicinal product products for IVD, RUO (research use only) and general laboratory equipment medical / cosmetic / hygienic purpose of products aids (accessories) Requirements of […]Read more
PROGRAM Classification: medical device for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration Conformity assessment performed by conformity assessment body: choosing the best procedure for your business application and documentation step-by-step description of the conformity assessment procedure through an audit of the manufacturing facilities special procedure for III class devices, […]Read more