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
Risk Management
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Podcast
A Complete Guide to Bringing a Medical Device to Market
A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets.
Risk Management
Design Controls
QMS
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
How to Maintain a QMS Compliant to MDR & IVDR
Your QMS should be your source of truth, but what happens when the requirements for a QMS change? Get equipped to meet EUMDR and IVDR standards by checking out this talk from Kyle Rose.
0 hr 52 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Webinar
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.
Device Classification
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
Standards and Pathways to the USA Medical Device Market
Anyone looking to launch a medical device into the United States market should be familiar with the FDA and the regulations they use. This course will give you a look at the regulations themselves and a little history on the FDA and how it came to be.
0 hr 42 min
Device Classification
QMS
510(k)
FDA
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
The Beginners Guide to Design Verification and Design Validation for Medical Devices
In this guide, we’ll go through the basics of design verification, design validation, best practices you should deploy, pitfalls you should avoid, and plans that will make it all come together.
Design Controls
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
Building a Regulatory Strategy
Your Regulatory Strategy is a lot more than just jumping through "regulatory hoops". It's your strategic pathway to getting a safe and effective device to market. It could even help you get funding if you have a solid foundation to show potential investors. Let's learn more in this course.
1 hr 14 min
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
