Question
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...
HiI am curretly updating our internal SOP's after a notified body audit found that we did not comply with the latest version of the ISO 14971 2012 Std. Specifically, I am interested in how others have updated SOP's to comply with Annex ZA and how thi...
In this post by David Amor, CEO of Medgineering, he breaks down what small med device companies should know about their quality systems and how FDA views themsource: https://www.linkedin.com/groups/2070969/2070969-6149239725870895105
This week I am in Brussels at an international conference on medical device regulations. The most popular topic of discussion is the new European Medical Device Regulations that was confirmed on May 25 and published on Monday—the first day of the con...
During the 10x conference in San Diego last month, we discussed the changes to the EU regulations for CE Marking. If you are interested in downloading the slide decks for free, please visit the following link:http://medicaldeviceacademy.com/10x-2016/...
Justyna-Wanda Niewiadomski, MBA
Director Group R&D Quality & Clinical Affairs Management bei Sonova Gruppe bei Sonova Gruppe
May 2016
To get an CE Mark for a device which needs to go to a clinical study and do not have any results to proof the safety and performance requirements. Is there a similar process/procedure in Europe like in Us for the IDE (Investigational Device Exemption...
In late 2014 and the beginning of 2015 I wrote a three-part series of blogs about controlling nonconforming product. The blogs explained the three steps for controlling nonconforming product: 1) identify and segregate, 2) disposition of nonconforming...
Hello All: In ISO 14971 Medical Devices--Application of Risk Management to Medical Devices clause 4.3 is "Identification of Hazards." It requires the manufacturer to compile documentation of known and foreseeable hazards associated with the medical d...
