#343: Recent FDA Draft Guidances

FromGlobal Medical Device Podcast powered by Greenlight Guru

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#343: Recent FDA Draft Guidances

FromGlobal Medical Device Podcast powered by Greenlight Guru

ratings:

Length:

54 minutes

Released:

Nov 9, 2023

Format:

Podcast episode

Description

Released:

Nov 9, 2023

Format:

Podcast episode

Titles in the series (100)

The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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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
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
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
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
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
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
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 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
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
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
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
The Intersection of Medical Device Usability and Risk Management: Today we’re going to be talking to our good friend Mike Drues from Vascular Sciences about the intersection of usability and risk management. There are so many tips and great pointers that you will not want to miss this show. Have a pen and paper or yo... by Global Medical Device Podcast powered by Greenlight Guru
31 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
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
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
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
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
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
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 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
How To Identify, Quantify & Manage Enterprise Risks for Medical Device Companies with Mike Cremeans 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
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
Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues: When it comes to moving from the conceptual phase of developing a medical device and actually doing first in-human studies, you first need to prove that your device is safe and effective. The documentation that goes along with that can be cumbersome, ... by Global Medical Device Podcast powered by Greenlight Guru
32 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
Understanding the Blurred Lines Between Consumer Tech and MedTech: Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? Pretty exciting news for the medical device industry, which is experiencing a crossover of traditionally consumer goods and technology. For example, he... by Global Medical Device Podcast powered by Greenlight Guru
34 min listen
Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission by Global Medical Device Podcast powered by Greenlight Guru
32 min listen
Tips & Pointers for Effective Internal Quality Audits with Kyle Rose: Internal audits might be inconvenient and a bit nerve-wracking, but they’re also educational. The objective of an internal auditing program is to help you understand your processes and learn about opportunities for improvement. It also protects your ... by Global Medical Device Podcast powered by Greenlight Guru
21 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

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#343: Recent FDA Draft Guidances

#343: Recent FDA Draft Guidances

Description

Titles in the series (100)

More Episodes from Global Medical Device Podcast powered by Greenlight Guru