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Product Development

UDI and the Current State of Global Implementation

August 17, 2022
What is the current state of unique device identification (UDI) in the United States versus the European Union (EU)? What are the current deadlines, complexities, and... Read More
Product Development

Ultimate Guide to UDI for Medical Devices

August 14, 2022
There are many global industries, but none quite like the world of medical devices. It’s not because we’re too niche or esoteric. It’s because no matter the device, the... Read More
Product Development

The Changing Job Market & How it Affects Careers for MedTech Quality Professionals

August 10, 2022
How is the changing job market affecting careers for professionals in MedTech? How can video storytelling strategies and techniques impact talent access? Read More
Product Development

How to Calculate Sample Size for Medical Device Studies

August 9, 2022
Sample size has always been one of the first design choices a medical device sponsor has to make for a clinical study. But the calculation of sample size is not the most... Read More
Product Development

What are the Risk Management Documentation Requirements of ISO 14971?

August 7, 2022
Managing risk is one of the most important areas in medical device manufacturing today. Not only does it protect users and patients, it’s also a major requirement of most... Read More
Product Development

Digitizing your SaMD Testing

August 3, 2022
What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing?  Read More
Product Development

Why is Post-Market Surveillance Important for Medical Devices?

August 2, 2022
The European Medical Device Regulation (EU MDR) is drastically changing the regulatory framework for medical devices. One of the new major challenges is the increased focus... Read More
Product Development

Why Training Compliance Matters for Pre-Market MedTech Startups

July 31, 2022
Medical device companies in the pre-market stage tend to put training compliance on the backburner. It’s not that there aren’t directions for achieving compliance—ISO 13485... Read More
Product Development

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

July 27, 2022
After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  Read More

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