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 ...
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...
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...
As originally asked by Olufemi Adeoye. Can someone provide me with estimates on how much ISO 13485 registrar (CMDCAS for Canada) and EU notified bodies charge for certification as well as how long it takes; considering 1) Specification developer/Auth...
Dear All.... Could anyone please let me know the procedure for "how to select and contact a Notified Body?"
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...
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...
I am working to compile a list of recommended MDR compliant EU Authorised Reps for small medical device manufacturers. Any suggestions are greatly appreciated.
Partner at Axon Lawyers
With the new EU Medical Devices Regulation and IVD Regulation more or less established now, let's take a look at the transparency requirements under these regulations. This presentation was delivered at Informa's MedTech Summit in Brussels on 14 June...