Question
Medical devices sold in Europe carry the CE Mark. Does anyone have a list of non-EU countries who also require the CE Mark? (e.g. the Saudi regulatory body will accept the mark)Thanks for your feedback!source: https://www.linkedin.com/groups/78665/78...
Many available sources of light therapy will deter the degeneration of Alzheimer's and TBI, non-invasively. However, until someone large enough to afford FDA approval undertakes the initiative, the tragic onslaught of dementia will continue. This vid...
EU representative for CE marking: is Israel consider an European address in your point of view?source: https://www.linkedin.com/groups/78665/78665-6161602791837044737
A client of mine recently asked me to help them plan a clinical study for a low-risk medical device. The company is located in the USA and they intend to launch the product is the USA first. At first I was shocked, because there was no clinical study...
Hello All,I came across situation where I am not sure what is optimal and really required. We have received IEC 60601-2-47 (ambulatory ECG recorder) and IEC 60601-1-2 (EMC) test reports from one of the well known testlabs. Now, Testlab has included c...
Jane Desrochers
Enthusiastic biomedical research engineer with expertise in tissue mechanics, medical imaging and engineering design
July 2016
I'm looking to change career direction into medical device design from academia and notice that so many job postings are for regulatory and quality assurance positions. Direct experience would be best, but if that's not realistic at the moment I'm cu...
The Brexit from the EU may be causing a few medical device manufacturers some anxiety over the future of their CE Certificates from British Notified Bodies (e.g., BSI and SGS). The following article discusses this issue briefly:http://www.raps.org/Re...
I was having a chat with a friend who was telling me how tech startups are coming up with technologies aimed to replace accountants. While this shift towards automation may not be something new, obviously we have start seeing McDonalds among many oth...
How do you see this changing going forward?Study: Initially CE Marked medical devices have higher recall rateU.S. medical devices which won CE Mark approval in the European Union prior to gaining FDA clearance have a nearly 3 times higher rate of saf...
Anyone here have any initial thoughts about the potential impact of Brexit on CE Marking?What is likely to happen with CE certifications issued by BSI or other MHRA-designated notified bodies?Is Brexit likely to have an impact on the process for fina...
