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On December 16, the final Digest-seminar “The most important regulatory changes in the field of medical devices 2021” was held, the speaker of which was Victoria Shevchenko, head of the conformity assessment department of UNI-CERT LLC. During the seminar, the impact of the updated requirements for cosmetics on the field of medical devices, new European Union legislation on medical devices, market surveillance and others were discussed.
The Pharmacy weekly # 50 has published a review article about this Digest Seminar 2021.
Full text of the article in Ukrainian
Quality management // № 4 (40), April 2021 The text of the article is available only in Ukrainian
Read morePROGRAM 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 morePROGRAM 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 […]
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