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Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong with David Amor - Featured Image

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong with David Amor

Today on the Global Medical Device Podcast we have a very interesting and highly debated topic for y...
Medical Device Product Development Project Management Best Practices with Peter Sebelius - Featured Image

Medical Device Product Development Project Management Best Practices with Peter Sebelius

Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the fo...
Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner - Featured Image

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

Standards are absolutely critical when you are developing a medical device. You need to understand w...
An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson, a Member of the Standard's Working Group - Featured Image

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson, a Member of the Standard's Working Group

Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later thi...
Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor - Featured Image

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

If you are in the business of medical devices, then you must eat, breathe, and live quality manageme...
Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey - Featured Image

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

In episode #10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt...
How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans - Featured Image

How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

In episode #9 of the Global Medical Device Podcast we’re joined by Mike Cremeans. Mike is the Vice P...
How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues - Featured Image

How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues

In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascu...
Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson - Featured Image

Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

On today's episode of the Global Medical Device Podcast, we’re discussing how startup entrepreneurs ...
How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken - Featured Image

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

What are the most common mistakes a startup medical device company usually make? Hear Ronny Bracken ...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.