Question
Caitlin Morse, PMP says you can minor in biomedical engineering, but – for your sake – don't major in it. If you do, you won't likely start as an engineer. Caitlin says, Many who are excited about going into medical device or other life science compa...
Hello, I'm wondering if there's a centralized publicly available list/ database of medical devices that have received the CE mark in Europe?Thanks for helping!Fiona
My wife Beth and I watched "Cut Poison Burn," a film about the business of cancer. See https://medgroup.biz/cut-poison-burn. It paints a bleak, one-sided view of FDA and big pharma and medical device companies and an active campaign against Texas-bas...
Chirag Khurana wrote: Hello All, I am starting a WhatsApp group to discuss business opportunities in India for Medical Device Manufacturers. The group will be dedicated to foreign manufacturers, who want to enter the Indian market and are interested ...
Danny Kroo
ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
January 2019
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...
No, I'm not kidding. We made our first investment in August, 2015. It was the first time we invested in a medical device startup. When selling Beth on the investment, I began, "I know this sounds cliched, but this is a sure thing." She gave me a...
As originally asked by Andrew Wallis. What is the average markup that a distributor adds on to the cost price for medical consumables? George Morphitis Director Dear Tzahi Alhough I agree with you that the Distributor knows better than anyone else th...
Consider the following: device OEM is in Germany, contract sterilisation is done in the UK, the OBL owner (and therefore Legal Manufacturer) is also in the UK. For labeling in the US market, which is the correct country of origin: Germany or the UK?s...
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 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...
