Question
Does anybody have a list of European countries Competent Authorities / Ministry of Health that require further communication/declaration/registration once the CE-mark obtained? Thank you for you help!source: https://www.linkedin.com/groups/2070960/20...
I would appreciate some input as to what other Companies have done in similar situations. An Authority has asked for the ISO 13485 Audit report to be sent in as a part of the Companies Authorization. To start with the Certificate was sent, then confi...
The UK's MHRA has been a leading influence in the European regulation of devices. What does Brexit mean for UK Medtech - and the broader regulation of devices in Europe?Brexit and the CE Mark - implications for European regulation of medical devicesT...
source: https://www.linkedin.com/groups/78665/78665-6174257174584320003
This man wants to receive the first human head transplant. http://medgroup.biz/new-head I don't even know where to begin with this one. Is this ethical? And the broader question, how much of you could we replace (prosthetics, major organs) and still ...
The most common way to answer this question is with a question.How long is a review supposed to take? orHow long does a review actually take?Most people want to know the answer to the second question, and they want real data to back it up. Therefore,...
Should medical device companies be held liable for off label use of their products? At what point does the liability for negative outcomes resulting from off label use shift from the physician to the manufacturer?Surgical device maker misled FDA, whi...
Nick Spooner
Trusted expert in breakthrough B2B & B2C Ecommerce for distributors and wholesalers
August 2016
Fear not I'm not selling anything, rather I'm looking to validate an idea for the development of an app which leverages information on the web to expose intelligence about who is looking to buy what device(s) and when they are going to buy. At this ...
Stephan van der Merwe
Design-Develop-Manufacture High Complexity Electronic Products. Director of Business Development - Extel Technologies
August 2016
TTM (time to market), Unit Cost, Features, R&D Cost or Risk?source: https://www.linkedin.com/groups/78665/78665-6172130207886036993
Hi. Would apprecaite input and/or referrals. I was just issued a utility patent for my medical device which is the 1st pelvic brace that supports all sides of the pelvis and has adjustable ice/heat therapy. It was designed for postpartum but has been...
