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
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 an app...
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...
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...
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 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...
First, I have to say how liberating it is to be writing you on my own site versus LinkedIn. I literally feel a wave of relief washing over me. First, I don't have to count characters. Second, I've already used italics(!), something LinkedIn doesn't ...
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 ...
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...
