Question
I do, and I asked my wife the same thing as we watched "The Immortalists," a documentary about Doctors Bill Andrews and Aubrey de Grey, who want to "live forever or die trying." It was a mind-expanding film. See http://medgroup.biz/the-immortalists P...
We extensively test and use independent verification and validation. What else do you find useful? source: https://www.linkedin.com/groups/78665/78665-6054306281655721986
âWe want to be like Apple!â I canât tell you how many times Iâve heard this from teams innovating new products. What they mean is they want their new products to be sleek, attractive, and easy to use â something that does not come easy to most med de...
3) Ensure the DoC includes all directives applicable to the product. Even though devices are governed by their âprimaryâ directive, a number of devices require compliance to other directives before the CE mark can be affixed, e.g. many electrical and...
What about hearingaids, what class are they ?source: https://www.linkedin.com/groups/78665/78665-6052865481788968962
The Declaration of Conformity (DoC) is arguably the most important document, from a regulatory perspective, that a medical device company shall draft and sign. It is the sole document that declares the product(s) listed conform to the regulations gov...
Hi, does a DFU of a medical device, must say the exact same thing which is written in the device's Spec.for example, if written in a spec that the value should not exceed 6 sec and in the DFU it is written (for the doctors whom actually use it) ~3 se...
I am curious to hear from the group about the top 3 issues medical device companies are facing with translation and localization. I am hearing:1 - Consistency across outputs (marketing, websites, tech pubs)2 - Sheer volume of translatable content (we...
Aurélie HOUEL
Directeur Assurance Qualité / Responsable Affaires Réglementaires Sécurité Produits chez SEPPIM SAS
September 2015
Hi,I hope to have some help on sterilization process with an autoclave which has no drying cycle.We use this autoclave to improve the state of cleanliness of our material used during the manufacturing process. We want to change this process, but I ne...
I have a good idea about i but what does people say about making DQ ?source: https://www.linkedin.com/groups/78665/78665-6051511599762599940
