PROGRAM
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 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, […]
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Read moreJournal “Standardization, certification, quality” № 4 (122)/2020 Over the past decades, the frequency of using software in various areas of human life has increased significantly. In particular, this product has taken an important place in the medical industry. For example, as an integral part of a medical device (software incorporated in medical devices or pacemaker […]
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