Product Development and Engineering for Medical Devices (Level 1)
Ready to take a learning journey with us? We've compiled all of our favorite content related to product development and engineering for medical devices, and we think you're going to love it. Finish this first leg of the journey and earn your Specialist Badge.
What is a Medical Device?
What actually counts as a medical device? Are there different types of medical devices? How do I begin to know what my regulatory path will be? Get the answers to these questions and more in this course!
0 hr 42 min
Show Overview
An Overview of Design Controls
What are Design Controls? What do the various regulations require in regards to Design Controls? These answers and more are available in this course so let's get started!
0 hr 28 min
Show Overview
An Overview of Risk Management
Learn about risk management for medical devices.
0 hr 28 min
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3 Systems of Risk for Medical Devices
Learn about the 3 systems of risk the FDA may use when evaluating your device submission and how you can manage each one.
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How to Embrace Risk for Safer Devices
Check out one of our favorite podcast episodes from the Global Medical Device Podcast with Tim Moulton, Founder and President at Motim Industries
Show Overview
Documenting Risk Management to Meet Requirements of ISO 14971:2019
A session by Edwin Bills, Consultant
0 hr 50 min
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A Step-By-Step Guide to Determine how your Medical Device will be Classified
In this guide, I will provide you with a step-by-step approach for determining how your medical device will be classified by U.S. FDA, the European Commission, and Health Canada. Getting a basic understanding of regulatory product classification will be invaluable to your efforts to bring new products to market.
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How Risk Management Can Help Drive Innovation
A session by Michael Quinn, Vice President of Design and Engineering at HS Design
0 hr 46 min
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The Ultimate Guide to Design Controls for Medical Device Companies
With this guide, Greenlight Guru founder Jon Speer shares valuable insights to explain what Design Controls are, how to address them, and how they benefit your medical device product development efforts.
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Product Development and Engineering Checkpoint Alpha
We are so excited you are on this journey with us! Unlock this course after completing Path 1 from the Product Development and Engineering collection and earn your Specialist Badge.
Show Overview
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