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Posted on November 22, 2022 at 1:47am 0 Comments 0 Likes
The technical documentation is prepared based on the general safety and performance requirements set out in Annex I of the medical device’s regulation. The purpose is to document the product’s characteristics based on an assessment of the product’s quality, safety and performance.
In addition, the documentation must include a …
ContinuePosted on October 20, 2022 at 5:13am 0 Comments 0 Likes
Clinical Evaluation gadgets comprise an extremely colossal and complex field. Gadgets can go from anything between a thermometer and a pacemaker. The FDA, the US' food and medication administrative body, has a definition for gadgets. It considers a clinical gadget as "an instrument, mechanical assembly, execute, machine, contraption, embed, in…
ContinuePosted on September 23, 2022 at 7:22am 0 Comments 0 Likes
A blog around the process and requirements of registering a medical device in the UK.
If you're planning on marketing a medical device in the UK, and haven't yet familiarized yourself with the registration process for medical devices, it's time to get started.
As a medical device importer or distributor located in the UK, you will have to comply with all relevant UK product regulations,…
ContinuePosted on August 22, 2022 at 4:54am 0 Comments 0 Likes
An EU Declaration of Conformity (also known as a Declaration of Conformity or DoC) is a mandatory document that you, as a manufacturer, must produce and sign if you manufacture, import, or distribute products for use in the EU. You must first draw up the technical documentation for the product, which includes, supports, and justifies the DoC
By…
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