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Product Development

CSV vs. CSA: Exploring FDA’s New Software Validation Approach

June 4, 2023
In September of 2022, FDA issued a new draft guidance on software validation: Computer Software Assurance for Production and Quality System Software. Read More
Establishing a QMS

Making the Business Case for an eQMS Solution for Your Company

June 2, 2023
As a MedTech Quality professional, you know that you need an eQMS solution. Working in a legacy or paper-based system can significantly impact your team’s overall speed and... Read More
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

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
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
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
Product Development

How To Vet Medical Device Distributors in Multiple Markets

May 15, 2023
The majority of medical device companies, even the relatively big ones, will need third-party distributors to get their devices to market. Read More

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