Question
We are importers and exporters of products and we are seeking to find trade shows in the USA /Canada where we can meet manufacturers of new products for the Hospital and Aged Care markets. We also represent an Australian bed manufacturer whose produc...
The example provided in the Practical Guide for the implementation of a “risk-based approach” contains a single, one-paragraph example outlines three steps:• SWOT “review your QMS to improve or verify compliance.” Back in my day, we called this an in...
To ring in the new year, https://medgroup.biz/pre510k. This is a three-hour replay and the 108 slides from David Amor and Jon Speer's presentation at last year's 10x Medical Device Conference. We're making them available this week for $59 (guests pai...
Theranos Secures $100 Million in New Funding from Fortress Capital The once-hailed blood-testing startup, led by CEO Elizabeth Holmes, was on the edge of bankruptcy.source: https://www.linkedin.com/groups/78665/78665-6351540835342905346
Medical device founders may clutch tightly to the idea of retaining as much NewCo stock as possible. They viscerally reject the idea of either losing their controlling authority or diluting their equity interest, or both. Early round investors, espec...
As originally asked by Ewan Savage. Julie O. I don't think the conclusion follows that barriers to entry will be lower. Martin Dewey What's a 'Wave 1 country' when it's at home..? Hannah Sampson Surely most companies selling into the EU will still ha...
With the end of the calendar year upon us, you'll be seeing top 10 lists for the year. And while I have two links to share with you, I'm more interested to learn which innovations and medtech startups made the most impact for you this year? Perhaps i...
I've been applying for months to Device jobs that couldn't be a better match for my experience, yet I genuinely have no clue if even 5% get through the internet HR vacuum. In the meantime I see new reps everywhere walking around the hospital clueless...
"I can't tell you how many companies said we just didn't bother protecting in China because they don't care. They'll copy anyway," said Landon Lack at this year's 10x Medical Device Conference. His entire talk here: https://medgroup.biz/Landon "You h...
I have just released the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” This post explores insights from the Practical Guide on “risk-based approach,” the varying terminology used to reference it, and the QMS p...
