Regulatory Manager at Solent Group
There are a few such products on the UK market that (from the CE mark and Notified Body number) are Class II devices. They are for sensitive teeth and I can almost understand how they could be pharmaceutical products since they have an active and spe...
I begin this conversation with a question: Which factor have you found to be most important in terms of setting a purchase price for a successful market launch: Hospital bundling, a desire on the part of the surgical/medical staff for the device, or ...
I stumbled upon a significant idea with regulatory and quality expert Michelle Lott last week. Seize it immediately! Here's that 9-minute conversation. Get or renew your CE mark TODAY! If you prefer reading, the conversation highlights are: Get or re...
President at Ombu Enterprises, LLC
Often I see companies performing design verification by manufacturing components, subassemblies, etc. and performing inspections and tests. In these instances, it appears to me that some device manufacturers have conflated design verification with ma...
Ship & Print Your FDA eCopy
Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. The most common question I am asked is, “How do you access the Eudamed database?” for reporting of...
Dear all, I have a question about RUO and IUO labeling in US market.According to FDA guidance "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only": RUO product is an IVD product that is in the labor...
CEO at Wallaby Medical
I'm trying to understand which countries' regulatory bodies have country of origin requirements and what does "country of origin" actually mean for these countries. Which countries have "country of origin" approval requirement for medical devices?If ...
As leader of the Medical Devices Group, I get asked multiple times per week by medical device sales candidates how they can break in to the medical device sales industry. I wish I had an easy answer, definitive resource, or job for them. I don't. But...
Senior Manager Regulatory Affairs-CMC at Alexion Pharmaceuticals, Inc.
Good morning everyone, I need some advice please! Hopefully someone can shed some light! The company manufactures IVD devices, and the QMS is currently in conformity with BS EN ISO 13485 (and all other applicable EN ISO Standards). Because we will al...
Mechanical Engineer excited to design and manufacture medical devices and assistive technologies.
I've been trying to find a list of materials approved for implant by the FDA with little luck. Can anyone point me towards such a list? Or do you have a personal list compiled over the years that I could use as a reference point? Application-wise, ri...