<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

Filter All Blog Posts

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.

Product Development

Ultimate Guide to Software as a Medical Device (SaMD)

June 19, 2022
It’s been more than a decade since Marc Andreesen famously wrote that “software is eating the world.” Since then, software has made its way into practically every industry,... 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

Design vs. Utility Patents: Choosing the Right One for Your Device

February 4, 2022
If you go through the rigors of designing and developing a medical device, it only makes sense that you’d want to protect your intellectual property from any late-comers who... Read More
Product Development

Understanding Product Realization under ISO 13485

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

Explaining IVDR Classification for In Vitro Medical Devices

November 19, 2021
The In Vitro Diagnostic Regulation (IVDR), which concerns in vitro diagnostic medical devices in the European Union market, is very different from its predecessor, the In... 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
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

Experience the Guru Edge

Our industry expertise extends beyond our software. Explore our other resources that are helping leading MedTech companies reach success.

Academy

Accelerate your learning and proficiency - both in Greenlight Guru solutions and industry best practices. You’ll be equipped to build key competencies for your teams.

Elevate Your Education
Community

You're not alone. We created a network of peers to connect with and learn from. At any stage of the product development lifecycle, become part of our community to accelerate your path to excellence.

Find Your Community
Partner Ecosystem

We have over 200 strategic partnerships with leading consultants in quality, regulatory, testing, design, and clinical.

Become a Partner
Resources

Do you have a unique problem that needs solving? Or maybe you’re just looking to elevate your expertise. If you're a MedTech professional looking to improve the quality of life for your patients, we have the right resources for you.

Explore Our Content Hub