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

Single Registration Number (SRN)

What exactly is an Single Registration Number (SRN)? The Single Registration Number (SRN) is a unique code that is used to identify an economic operator in the EU without ambiguity. The SRN number is generated by EUDAMED and issued by the competent authority who validated the Actor registration request in EUDAMED. Manufacturers must apply [...]

By |2021-08-28T06:26:08+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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