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...

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...

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 ...

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...

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...

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...

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...