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FDA Regulations

Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

June 22, 2022
What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA’s approach... Read More
Regulatory Affairs

Ultimate Guide to Software as a Medical Device (SaMD)

June 19, 2022
It’s been more than a decade since Marc Andreesen famously wrote that “software is eating the world.” Since then, software has made its way into practically every industry,... Read More
Global Medical Device Podcast

What Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation?

June 16, 2022
How does a quality management system (QMS) and regulatory affairs impact fundraising, pre-money valuation, market access, and commercialization for medical device... Read More
Regulatory Affairs

Who are the Economic Operators & What Does EU MDR Require of Them?

June 5, 2022
There are four legal entities designated as economic operators under the European Union Medical Device Regulation (EU MDR):  Manufacturers Importers Distributors Read More
Regulatory Affairs

Setting up a Clinical Investigation under EU MDR

May 26, 2022
The European Union Medical Device Regulation (EU MDR) defines a clinical investigation as “any systematic investigation involving one or more human subjects, undertaken to... Read More
FDA Regulations

Demystifying the De Novo Process

May 12, 2022
How do you navigate the De Novo process for your medical device? When do you decide to go that route rather than with other FDA submission pathways, such as Q-Sub,... Read More
Global Medical Device Podcast

Challenges for Regulatory Submission: EU vs. US

May 6, 2022
What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing with regulators can be challenging and emotionally draining. Win in... Read More
Regulatory Affairs

30/60/90 Day Plan to Making an Impact as a New QA/RA Manager

May 1, 2022
Starting a new job is always a little stressful. But when you’re a new QA/RA Manager, there’s even more pressure than usual. It’s not a stretch to say that the fate of this... Read More
Global Medical Device Podcast

Bridging the Gap between Medical Devices and Clinical Data

April 20, 2022
Selling a medical device in the EU? Understanding the importance of clinical data and what's required will be crucial to your success.  Read More

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