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Post-Market Surveillance

How to Comply with HIPAA and EU GDPR in Medical Device Studies

August 17, 2023
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the US and the EU have regulations in place... Read More
Post-Market Surveillance

Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting

August 4, 2023
The latest SMART-TRIAL by Greenlight Guru update includes a newly designed Reporting module that streamlines clinical data management for scaling medical device companies. By... Read More
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In September of 2022, FDA issued a new draft guidance on software validation: Computer Software Assurance for Production and Quality System Software.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
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
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

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