Pathways to get your Device to Market

Pathways to get your Device to Market

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Standards and Pathways to the USA Medical Device Market
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
Standards and Pathways to the EU Medical Device Market
Standards and Pathways to the EU Medical Device Market
There have been many changes to the process of bringing a medical device to market in the EU. This course will highlight a bit of that history as well as best practices for the current state of the EU MDR.
0 hr 42 min
EU MDR Device Classification QMS Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Course
Regulatory Pathways Round Table
Regulatory Pathways Round Table
0 hr 32 min
EU MDR IVDR ISO 13485 FDA Regulatory Management QMS Refinement & Regulatory Submissions Advance Exclusive Webinar
A Step-By-Step Guide to Determine how your Medical Device will be Classified
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

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