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About the Author

Wade Schroeder is a Medical Device Guru at Greenlight Guru with a noticeable enjoyment of medical device product development processes. As an electrical engineer by trade, he began his career developing medical exam procedure chairs and later designing IVD devices. He has been a risk management enthusiast since the beginning and enjoys helping customers develop design processes that their team can be proud of and enjoy. He believes the best part of working with customers is helping them implement a culture of true quality within their team.

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Product Development

Software as a Medical Device: Definitions, Examples & Regulatory Framework

October 14, 2021
Software as a Medical Device (SaMD) is a technology with limitless possibilities. In the hands of talented engineers and developers, it’s an infinite toolbox that can improve... Read More
Product Development

3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers

September 6, 2021
Software as a Medical Device (SaMD) is a rapidly growing subset of the medical device industry, and many companies with software development capabilities are branching out... Read More
Product Development

7 Documentation Musts for All Software Device Premarket Submissions

August 8, 2021
As the prevalence of software in medical devices and software as medical devices (SaMD) has increased, medical device regulators have been forced to keep up. Read More
Product Development

How to Apply IEC 62304 Requirements for Medical Device Software

July 18, 2021
If you’re developing a medical device that uses software, or developing SaMD (Software as a Medical Device), then it’s important to understand and follow the applicable... Read More
Product Development

Cybersecurity for Medical Devices: Best Practices from Regulatory Standards

July 11, 2021
As more and more medical devices utilizing network connection technology are developed, cybersecurity will continue to grow in terms of importance and focus among regulators... Read More
Product Development

4 Reasons to Get ISO 27001 Certification

May 7, 2021
The average data breach costs a company $3.86 million dollars. Perhaps worse than the financial burden is the toll that data breaches take on your brand’s reputation. When... Read More
Product Development

How to Build Medical Device Usability Testing and Validation into Your Quality System

May 2, 2021
Medical device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your... Read More
Product Development

Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?

February 21, 2021
If your medical device falls under premarket submission criteria, there are three types of 510(k) that you can choose from. Read More
Regulatory Submission

Tips for Success with IEC 60601 for Electrical Medical Devices

November 10, 2019
Does your company develop electrical medical devices? The standard IEC 60601 is different from other regulatory compliance processes, so it can be challenging for medical... Read More

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