Question
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...
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...
When UK-based EnXray, makers of the first low-energy X-ray sterilization tech, needed ÂŁ400,000 to scale its manufacturing to hit 2018 sales projections, it turned to Crowdcube. And fantastic-looking carbon-fiber wheelchair manufacturer Carbon Black i...
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...
I get asked the same questions all the time. "Joe, I am looking for a new position and/or I'm looking for new clients for my consultancy. Do you know of any opportunities for me?" "Joe, I am looking for sales representatives (1099) and/or distributor...
Hi all,I was wondering what exactly a Qualified Person (QP) in the field of medical devices does and means? According to some sources which I am reading, it says “Manufacturers shall have available within their organization at least one qualified per...
Hi all, I am looking for a simple protocol to file a 510k exempt device to FDA, since FDA provides so much detailed information of 510k and PMA on the website. I will be grateful if someone could share some simple tips of what I should do for the 510...
If you ask “how much less documentation is required for the design of a Class 1 device compared with a Class 2 device?” you get a very different answer. Instead of 0% (Yes a DHF is required) of 100% (No DHF required), the answer is that you need 33% ...
I met a molecular biologist last week at BRINK 2015 (which was excellent). He's turned his attention to oncology. I paraphrase, but he basically asked if we knew any billionaires with cancer. He wasn't being elitist. Or looking to deny service to any...
Thoughts - A device such as ultrasound device, whose life span is 5 years. In its 6th year device does not work properly. The customer calls the manufacturer. The manufacturer offers to repair the device even though the device is outside its lifespan...
