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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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Establishing a QMS

ALM and Design Controls: Do SaMD and SiMD Manufacturers Need Both?

February 26, 2024
One consequence of the massive growth of software as a medical device (SaMD) and software in a medical device (SiMD) is the growing overlap between the realms of software... Read More
Establishing a QMS

How MHRA is Regulating Medical Devices in the UK after Brexit

February 22, 2024
If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in the regulatory landscape resulting from Brexit are relevant to you. Read More
Product Development

Ultimate Guide to Software as a Medical Device (SaMD)

October 30, 2023
Only recently has the medical device industry began designing software-based products that have no direct relationship to hardware devices at all. Read More
Product Development

Explaining IVDR Classification for In Vitro Medical Devices

March 23, 2023
What is IVDR? The In Vitro Diagnostic Regulation (IVDR) is a European Union regulation applicable to in vitro diagnostic medical devices. It establishes a risk-based... Read More
Product Development

Software Bill of Materials: What to Know About SBOMs for Medical Devices

February 18, 2022
On May 12, 2021, President Biden signed the Executive Order On Improving the Nation’s Cybersecurity. Among other items in the executive order was a requirement that every... Read More
Product Development

Understanding Product Realization under ISO 13485:2016

December 14, 2021
Medical devices always begin the same way: as an idea. And while ideas are an invaluable resource, they are not enough to take a blueprint or sketch to a marketable,... Read More
Product Development

UDI: Everything You Need to Know About Unique Device Identifiers for the FDA

December 10, 2021
Every aspect of the medical device industry needs to be built on the highest standards for quality and safety. While it’s never an outcome anyone wants to think about, there... Read More
Product Development

What are the SaMD Requirements from FDA?

November 10, 2021
The market for software as a medical device (SaMD) is growing rapidly as more companies see the possibilities inherent in leveraging their software development expertise for... Read More
Product Development

Clinical Testing for Medical Devices: What US Manufacturers Need to Know

October 21, 2021
Clinical testing of medical devices is a critically important step in ensuring the safety and efficacy of medium to high risk products. It’s one of the presumed protections... Read More

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