Guest author Mark Proulx has seen a lot of head-shaking choices from prospective clients. I say "prospective" because, after conversations like the one below, he stayed clear of their impending disaster. Do yourself a favor: Don't say this to your au...
Those wonderful devices you made, perfectly calibrated when customers opened the box, are still your responsibility once deployed.This guest post, courtesy of Gregg Schaeppi, Director of Client Services for PK Calibration & Validation, taught me ever...
Head of Quality and Regulatory Affairs
Hi all, I was wondering if anyone had much experience with the safety and performance guidance that came in at the start of Feb? I was trying to find the list of eligible device types but have had no luck as yet.
You have a milestone. To achieve it, you need research… so you search. In-house? Crazy talk. Contract Research Organization? Your budget is too small.The University down the road? Now we're talking, you think. They have smart people, cutting-edge equ...
Mike Drues is one of the most gifted regulatory people I know. At 10x he said, If you're going to change a medical device in an administrative way, you have two options to handle that. • You notify the FDA (and if you do, how?); or, • You don't notif...
I am working to compile a list of recommended MDR compliant EU Authorised Reps for small medical device manufacturers. Any suggestions are greatly appreciated.
| President, Electronics, Software Design | Expert Speaker in Wearables, Wireless, Medical Devices, Consumer Products |
We are starting to see smart toilets enter the market or get close to entering the market. They include sensors such as electrocardiogram, body temperature, and photoplethysmogram to measure blood oxygen level.What do you think? Is it a medical devic...
Dear All.... Could anyone please let me know the procedure for "how to select and contact a Notified Body?"
ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
A company is interested in getting a private label agreement with an OEM to sell a Class II medical device in the USA. The OEM has 510(k) clearance and the only product change will be the company's name on the label. There will be no change for the i...
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...