Question
“We want to be like Apple!” I can’t tell you how many times I’ve heard this from teams innovating new products. What they mean is they want their new products to be sleek, attractive, and easy to use – something that does not come easy to most med de...
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 ...
3) Ensure the DoC includes all directives applicable to the product. Even though devices are governed by their ‘primary’ 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...
During the next three years I guarantee that every single medical device manufacturer will eventually become sick and tired of hearing the phrase “risk-based approach.” I’ve been there for about 5 years, but there are a few new updates to the standar...
Think it's easier to launch in Europe with a CE Mark and get FDA clearance later? Then you'll want to attend http://medgroup.biz/New-CE-Marking-Rules, a free webinar we're hosting for group members on October 6. The latest adopted draft says you'll n...
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...
I have a good idea about i but what does people say about making DQ ?source: https://www.linkedin.com/groups/78665/78665-6051511599762599940
