Question
There are 11 different types of software validation documents that the FDA requires. One of the documents is a rationale for the "Level of Concern." Level of Concern (LOC) is a term that the FDA uses to categorize the risk of software as a medical de...
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...
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...
I have been researching online for some information regarding clean rooms. I do perform some work on what I think is a ISO class 7 or less. Linear flow, HEPA filter etc.What I wonder, is what is a "ISO Class 9", considering that air conditions are eq...
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...
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...
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...
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 ...
Elizabeth Doyle
Mechanical Engineer excited to design and manufacture medical devices and assistive technologies.
March 2018
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...
It appears this topic was covered in this forum back in 2012 and the HIDA conference was suggested as a possible resource. I've heard both positive and negative experiences concerning finding medical device distribution partners at HIDA and was hopin...
