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At what point in your CE process do you look at translating your product documentation? Is this part of your overall plan or handled market by market, as you branch into new regions?source: https://www.linkedin.com/groups/78665/78665-6146449808384147...

Dear fellow professional,I would like to ask your opinion on what follow.Thank you to all the contributors.According to MEDDEV 2.1/1 and Directive 93/42/CE, the intended use of the accessory must be such as to enable a device to be used in accordance...

The most common nonconformity identified by reviewers of a CE Marking submission is an inadequate or missing clinical evaluation report (CER). Preparing a CER is time consuming, but if you have a good protocol and procedure the process does not need ...

Since the EN version of ISO 14971 was released in 2012 I have received lots of requests from clients to help address nonconformities from Notified Body auditors. In the past year the frequency of this nonconformity has increased substantially.The FDA...

If you have a moderate risk device you probably will submit a 510(k) before applying for CE Marking, because some of the requirements for a technical file are more challenging than European requirements.Risk Management FileThe FDA only requires docum...

Hiwhat are the rules/cost/time please around a "same as" CE marking application form? in Europe, for a medical device product with CE marking for a cosmetic surgery usage: I would need to change the name (can I use any name?) of the very same device ...