Attributes of Biological Evaluation

B Biological Evaluation is estimation of biological responses of the product to ensure safety and efficacy with patient and user. Biological Evaluation of Medical Devices is a series of tests performed with the help of international standards pre-clinically either through In-vitro or In-vivo techniques and may upon animal models to assess the biological safety [...]

By |2021-10-03T03:32:46+00:00June 22nd, 2021|EU CE|0 Comments

Literature Search and Clinical Evaluation

The basis of your device CERs is Literature Search. If you're in charge of compliance for a number of goods, you're well aware that EU MDR presents a significant challenge to your team and current timeframes. If you're a smaller manufacturer, you're probably just dealing with one or two people who are responsible for [...]

By |2021-09-24T12:02:18+00:00July 2nd, 2015|UK CA|0 Comments

User Manual Requirements for Medical Devices

A information supplied by the manufacturer to inform the user of a product's intended purpose and appropriate use is referred to as "instructions for use." The following items must be present in the information provided with the directions for use: Information in line with Section 23.2 of the MDR points (a), (c), (e), (f), [...]

By |2021-08-28T06:29:23+00:00July 2nd, 2015|EU CE|0 Comments

Actor Registration

All economic operators  in the European territory  and non-EU manufacturers, authorized representatives, system/procedure pack producers, and importers must register as an actor in EUDAMED and provide the required data. The actor registration module of the European Commission's Eudamed database, which is a critical component of the EU's Medical Devices Regulation (MDR) and In Vitro Diagnostic [...]

By |2021-08-28T06:28:07+00:00July 2nd, 2015|EU CE|0 Comments
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