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Wade Schroeder

Wade Schroeder
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.

Author's Posts

How to Apply IEC 62304 Requirements for Medical Device Software - Featured Image

How to Apply IEC 62304 Requirements for Medical Device Software

If you’re developing a medical device that uses software, or developing SaMD (Software as a Medical ...
Cybersecurity for Medical Devices: Best Practices from Regulatory Standards - Featured Image

Cybersecurity for Medical Devices: Best Practices from Regulatory Standards

As more and more medical devices utilizing network connection technology are developed, cybersecurit...
How MHRA is Regulating Medical Devices in the UK after Brexit - Featured Image

How MHRA is Regulating Medical Devices in the UK after Brexit

If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in ...
4 Reasons to Get ISO 27001 Certification - Featured Image

4 Reasons to Get ISO 27001 Certification

The average data breach costs a company $3.86 million dollars. Perhaps worse than the financial burd...
How to Build Medical Device Usability Testing and Validation into Your Quality System - Featured Image

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

Medical device usability testing and validation are critical tasks leading up to a medical device’s ...
Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device? - Featured Image

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

If your medical device falls under premarket submission criteria, there are three types of 510(k) th...
Tips for Success with IEC 60601 for Electrical Medical Devices - Featured Image

Tips for Success with IEC 60601 for Electrical Medical Devices

Does your company develop electrical medical devices? The standard IEC 60601 is different from other...

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