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Product Development

Managing Major Changes to Medical Device Packaging

May 29, 2023
Charles Darwin famously said, “It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change.”... Read More
Product Development

5 Tips for Designing a Medical Device Study Under FDA Requirements

May 26, 2023
Let’s face it—medical device clinical studies are no walk in the park. There are so many variables to consider, such as patient recruitment, study design, and regulatory... Read More
Product Development

What is a Modern QMS?

May 26, 2023
For medical device companies, the role of the quality management system (QMS) has greatly evolved—in both form and function. Read More
Establishing a QMS

2023 Greenlight Guru True Quality Roadshow: San Jose Recap

May 24, 2023
Yes way, San Jose! On April 20th, the Greenlight Guru True Quality Roadshow landed in San Jose, California for its second stop of the 2023 tour. Unsurprisingly, the Bay Area... Read More
Product Development

4 Tips for Managing Your MedTech Portfolio

May 24, 2023
There’s no doubt that MedTech is a noble industry, built on the mission of improving the quality of life with impactful medical devices. Read More
MedTech Lifecycle Excellence

Ad Promo and The Difference in Regulatory & Legal

May 24, 2023
What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it... Read More
Product Development

How To Use FDA’s Guidance on Post-Approval Studies During Premarket Approval

May 24, 2023
In the US, post-market clinical studies are not required of every medical device manufacturer. However, FDA does have the authority to order post-market surveillance of any... Read More
MedTech Lifecycle Excellence

How AI Can Help You Manage Risk

May 17, 2023
With the advent of new Artificial Intelligence (AI) tools, where is risk management headed? How are they affected by the changes? Risk management is essential and... Read More
Product Development

The Risk Management + Design Controls Connection: What Device Makers Need to Know

May 16, 2023
Medical devices are intended to save and improve quality of life. Read More

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