I am working to compile a list of recommended MDR compliant EU Authorised Reps for small medical device manufacturers. Any suggestions are greatly appreciated.
Dear All.... Could anyone please let me know the procedure for "how to select and contact a Notified Body?"
Regulatory Affairs - MEDKONSULT medical technology
Hi, I have some doubts about conformity assessment of IIa MD. We apply Annex II with exclusion of section 4. When we launch a new MD or when we make any substantial change, we always undergo an approval process with our NB.Recently, I have come acros...
ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
Hello everyone, what are the requirements for selling first aid kits in USA?The first aid kits will include medical gloves, BZK swabs and alcohol prep pads and the suppliers of each will be FDA approved for these products.What needs to be done to get...
Juan Ángel Gracia García
Technical Director Medical Device Department
Under the European Regulation there are many cosmetic products with very low amounts of acidic components (such as glycolic acid, trichloroacetic acid, salicylic acid, lactic acid, etc).Active ingredients in higher concentrations (such as in the case...
First, I have to say how liberating it is to be writing you on my own site versus LinkedIn. I literally feel a wave of relief washing over me. First, I don't have to count characters. Second, I've already used italics(!), something LinkedIn doesn't ...
I was not completely aware to Medicare & Medicaid Services (CMS) agency. It regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments and approve Laboratory Developed...
Endeavor, optimism and joy of life among great people
The real case is: A medical device is already long time on EU market and serving well to patients. Post market clinical follow-up have been performed and it delivered a lot of new clinical evidence which has been used in technical file of the medical...
Associate Director of Marketing at Morningside Translations
The FDA has announced a plan to work with IBM and their AI program Watson to develop new ways to exchange health data across a variety of different platforms. Medical Device Daily has more:http://www.medicaldevicedaily.com/servlet/com.accumedia.web.D...
Principal Consultant at Class Three, LLC
It's been two years since FDA published its draft “direct to De novo” guidance, on August 14, 2014. Although many of the classification requests that have been submitted since that date are still under review, this seems like a good time to take a pr...