Question
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...
Hello everyone, Recently, I have been dealing with some troubles with documentation required for registration in non-EU countries, especially on Asian markets. We are a manufacturer of active devices with measuring function class IIa and we deliver o...
I found the "The Eye Doctor Essential®" on Amazon. What would be the device classification according to the new MDR? I believe it would be a Class IIa because it produces heat. Is this right? Thanks you!
Hi! We've been having a long discussion with a Notified Body and we aren't satisfied with the answer.There is a ME1 device which is connected to mains plug (230 V - 50 Hz input) and is totally reinforced and insulated. The sample (ME2) is connected t...
Hi All. I was wondering if anyone has seen a big move away from producing documentation (exc NB submissions etc) in these modern times! Before anyone has a heart attack, I will try and explain.With the vast array of software tools at our disposable, ...
Danny Kroo
ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
December 2018
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...
Simply a gift for you today. If you have anything to do with medical device quality systems, click here for FDA slides for immediate download. Four slides that stood out to me It was hard to narrow down the four hours from four presentations to four ...
I am reading the MDR again and am trying to get deeper knowledge. If an organization is transitioning to MDR and has class IIa/b devices on the market, how might they get around the requirement of clinical studies or equivalence?
I know a guy who got a $500,000 grant to make FDA data easier to search. As it neared completion, it was scuttled by two employees whose jobs would be jeopardized. Infuriating. So the answer to "which is the most frustrating FDA database" is probably...
José M. Montero
Technical Translations by Experts🔹Expert in Engineering🔹Expert in Medical Devices🔹Book a FREE consulting service⬇️
November 2018
Dear group-fellows, could you help Mediwords to get a better understanding of current MDR2017/745 awareness status so far in the industry? It won't take you more than one minute and no single personal data is collected, unless you willingly provide i...
