News

11.10.2021

How to make interlaboratory comparisons of test methods

PharmaTechExpo Journal | SPECIAL ISSUE 2021 The text of the article is available only in Ukrainian

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20.09.2021

Remote audits of global manufacturers of medical devices

Journal “Laboratory” No. 08/2020 The text of the article is available only in Ukrainian

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06.09.2021

Certification of medical device manufacturing by pharmaceutical companies

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 […]

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26.08.2021

Regulatory requirements for medical devices in laboratory practice

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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26.08.2021

Medical devices in the nomenclature of pharmaceutical manufacturers. Conformity assessment of in-vitro diagnostic medical devices

PROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing […]

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01.06.2021

Documenting the quality management system for the production of medical products according to ISO 13485:2018

Quality management // № 5 (41), May 2021 The text of the article is available only in Ukrainian

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