3 weeks ago
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...
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...
| 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...
Regulatory Affairs - MEDKONSULT medical technology
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!
Ata Gürül Arslanlı
LVT Test Laboratuvarları şirketinde Elektrik Mühendisi
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...
Head of Quality and Regulatory Affairs
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, ...
Quality Assurance Specialist at Blackrock Microsystems
Does a medical device manufacturer have to re-label research only products (animal research only, not for use in humans) as investigational use (per 21 CFR 812) for use in IRB or IDE?The devices are not cleared and some may or may not be on a path to...
Sr. Quality Assurance and Compliance at Prevas AB
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?
José M. Montero
Technical Translations by Experts🔹Expert in Engineering🔹Expert in Medical Devices🔹Book a FREE consulting service⬇️
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...