What are the Strategic Priorities for CDRH in 2021?

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson: Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later this month. The quality management standard we’ve all grown to know is now being updated, and we’ll explain more on this episode of the Global Medical De... by Global Medical Device Podcast powered by Greenlight Guru

29 min listen

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development: 3D printing can impact new product development and manufacturing. It’s a technology that is hot in many different industries, including medical device development. It’s been around for several decades, and now more than 85 devices are on the market... by Global Medical Device Podcast powered by Greenlight Guru

32 min listen

Tips to Help You Prepare for an FDA Inspection: On today’s episode, we’re introducing the newest addition to the greenlight.guru team, Jessica Lyons. Jessica is a 2007 graduate of Rose-Hulman Institute of Technology and has worked in the medical device product development for nearly 10 years. She ... by Global Medical Device Podcast powered by Greenlight Guru

30 min listen

Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner: If you are part of an organization developing or producing Class II medical devices, you should know that on September 24, 2016, your UDI submissions are due to the FDA. “I don’t mean to scare anyone, but we only have 78 working days left.” - Gary San... by Global Medical Device Podcast powered by Greenlight Guru

23 min listen

Lessons to Be Learned From Recent FDA Inspections: Something that you might find surprising is the number of medical device companies that are simply not prepared for an FDA inspection. The bottom line is that you should expect to be inspected. Today we’re going to be talking to Mike Drues, the preside... by Global Medical Device Podcast powered by Greenlight Guru

37 min listen

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?: As medical device developers, it is our responsibilities to make sure that our products are safe and effective. Unfortunately, the recent high profile cases of antibiotic-resistant superbugs spread by tainted endoscopes that have sicken many have call... by Global Medical Device Podcast powered by Greenlight Guru

28 min listen

The Difference Between Intended Use and Indications of Use with Mike Drues: It’s time to break down the how and why of intended use and indications of use statements for your new medical device. On this episode of the Global Medical Device podcast we’ll explain the differences between these two statements and how you can des... by Global Medical Device Podcast powered by Greenlight Guru

21 min listen

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues: In order to get your medical device to market, you will need to know about pre-submission and the pre-submission process. The FDA is trying to get the safest medical devices out there. The most common reasons that the FDA makes rejections is within t... by Global Medical Device Podcast powered by Greenlight Guru

31 min listen

Risk Management from a Regulatory & Product Development Point of View: Risk management for medical devices from a regulatory and product development perspective is the topic of today’s podcast. We take a look at a few tools to help in the process and liability as it relates to on-label vs off-label use (Some really inte... by Global Medical Device Podcast powered by Greenlight Guru

23 min listen

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 management systems. In order to get to market and sell your products successfully, your quality system needs to be right-sized, and meeting all of the regulatio... by Global Medical Device Podcast powered by Greenlight Guru

26 min listen

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 founder of Gantus.com and today we’ll talk medical device product development and project management. Peter is a certified PM and has vast experience in... by Global Medical Device Podcast powered by Greenlight Guru

23 min listen

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong: Today on the Global Medical Device Podcast we have a very interesting and highly debated topic for you around research vs. development for medical device companies. We’ll challenge some conventional wisdom on the subject and dig into when ‘R’ should e... by Global Medical Device Podcast powered by Greenlight Guru

27 min listen

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It: My guest today is Juan Carlos Serna, the co-founder of Right Submission. If you have been in the medical device business very long you know that 510k submissions for the FDA are a long, tedious, frustrating, and all round painfully experience. Juan Car... by Global Medical Device Podcast powered by Greenlight Guru

31 min listen

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions: The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draft guidance was issued last summer and the final guidance was issued in August. So what does Real-world Evidence mean for you and from a regulatory persp... by Global Medical Device Podcast powered by Greenlight Guru

36 min listen

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 why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to i... by Global Medical Device Podcast powered by Greenlight Guru

28 min listen

Integrating Business Elements into Your Product Development Process with Therese Graff: On today’s episode of the Global Medical Device podcast, we’re talking about the importance of incorporating business elements into your medical device product development process. When firms focus only on design controls, they may not experience the ... by Global Medical Device Podcast powered by Greenlight Guru

30 min listen

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso: Getting started in the medical product development process can be a huge undertaking. You might have an excellent idea, but maybe you’re unsure about where to start. Whether you’re just beginning to research, you’re starting to look for development p... by Global Medical Device Podcast powered by Greenlight Guru

27 min listen

Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer: One important piece of documentation that medical device companies rely on to get them through the regulatory process is the premarket notification 510(k). Since the FDA will refuse to accept submissions that are missing the appropriate documentation... by Global Medical Device Podcast powered by Greenlight Guru

30 min listen

Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's: In today’s episode of the Global Medical Device Podcast Jon Speer welcomes Sara Naab to the show. Sara is the co-founder and director of quality and marketing for Sandstone Diagnostics. Sara shares with us insights into what it’s been like going fro... by Global Medical Device Podcast powered by Greenlight Guru

21 min listen

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 like you can remove the common regulatory obstacles your business faces and other tips and pointers you can use when developing new medical devices. Ou... by Global Medical Device Podcast powered by Greenlight Guru

30 min listen

Understanding FDA’s Proposed Conformity Assessment Pilot Program: Today on the Global Medical Device Podcast, we’ll be talking to Mike Drues, who is a frequent guest on our show. He’s the president of Vascular Sciences and a guru on all things related to regulatory compliance for medical device companies. We’ll be ... by Global Medical Device Podcast powered by Greenlight Guru

32 min listen

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two): FDA Pre-submissions: They're a hot, timely topic. We had a recent episode on the pre-submission process, but because there is so much to know, we decided to have our expert speaker, Mike Drues, back to make sure our listeners have the information nece... by Global Medical Device Podcast powered by Greenlight Guru

33 min listen

Best Practices for Implementing Design Controls for the Medical Device Industry: If you're like many in the medical device industry, you've probably had some questions at one time or another around the FDA's Design Control Guidance. And if you're anything like the guests on today's podcast, you've probably gone through a lot of tr... by Global Medical Device Podcast powered by Greenlight Guru

27 min listen

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken by Global Medical Device Podcast powered by Greenlight Guru

23 min listen

How To Improve Your Medical Device Design Reviews: With nearly half a century of combine experience performing medical device Design Reviews between them; Michael Drues Ph.D., Jason McKibbin, and Jon Speer have the battle scars they want to help you to avoid. They peel back the lens on what has worked... by Global Medical Device Podcast powered by Greenlight Guru

24 min listen

What Device Makers Need to Know About Design Verification and Validation with Mike Drues: Here’s a question for our listeners: When it comes to making sure your medical devices are safe and effective, is it more important to find the right answers or to ask the right questions? In this episode of the Global Medical Device podcast, we are d... by Global Medical Device Podcast powered by Greenlight Guru

31 min listen

What You Need to Know About The FDA CDRH Experiential Learning Program: FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medical device companies, manufacturers, and service providers to discuss biocompatibility, in vitro diagnostics, clinical trials, and other areas. On today’... by Global Medical Device Podcast powered by Greenlight Guru

31 min listen

How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues: We’ve got a good one for you today. In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascular Sciences. As many of our listen may recall, Mike does consulting for medical device companies, the FDA, Health C... by Global Medical Device Podcast powered by Greenlight Guru

26 min listen

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?: Superbugs. Reprocessing. The White House. And Design Controls. Probably not a combo of topics you see grouped together very often. But we have them all for you on today’s Global Medical Device Podcast. This is the 2nd edition in our series focus... by Global Medical Device Podcast powered by Greenlight Guru

25 min listen

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 is a project manager for the Azzur Group and has been involved with many medical device projects. He was a founding employee and executive team member a... by Global Medical Device Podcast powered by Greenlight Guru

25 min listen

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What are the Strategic Priorities for CDRH in 2021?

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