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Greenlight Guru Medical Device Blog

Get the latest updates and best practices in the MedTech industry from our blog. Join 170,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Nick Tippmann
June 16, 2022

MedTech Lifecycle Excellence: Out of the Dark and into the Age of Enlightened Quality

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Establishing a QMS

Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL

Nick Tippmann
June 2, 2022
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Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Jon Speer
June 11, 2021
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Product Development

What are the Risk Management Documentation Requirements of ISO 14971?

Etienne Nichols
August 7, 2022
Managing risk is one of the most important areas in medical device manufacturing today. Not only does it protect users and patients, it’s also a major requirement of most... Read More
Product Development

3 ISO Compliance Guidelines Every Medical Device Manufacturer Should Follow

Etienne Nichols
August 5, 2022
The word “compliance” can sound like a chore,  or some sort of box to check before punching out at 5:00. However, in the medical device industry, compliance is more than a... Read More
Product Development

Digitizing your SaMD Testing

Nick Tippmann
August 3, 2022
What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing?  Read More
Product Development

Why is Post-Market Surveillance Important for Medical Devices?

Jon Bergsteinsson
August 2, 2022
The European Medical Device Regulation (EU MDR) is drastically changing the regulatory framework for medical devices. One of the new major challenges is the increased focus... Read More
Product Development

Why Training Compliance Matters for Pre-Market MedTech Startups

Etienne Nichols
July 31, 2022
Medical device companies in the pre-market stage tend to put training compliance on the backburner. It’s not that there aren’t directions for achieving compliance—ISO 13485... Read More
Product Development

3 Common Problems with Design Controls (and the Solutions)

Etienne Nichols
July 29, 2022
The first time you looked at 21 CFR Part 820.30—FDA’s regulations for design control—you probably thought, “Is that it?” Read More
Product Development

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

Nick Tippmann
July 27, 2022
After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  Read More
Product Development

Integrating Connected Device Data into Your Clinical Study

Jon Bergsteinsson
July 26, 2022
Connected devices are devices that may or may not be approved/cleared medical devices. They can be used in multiple places, e.g., a device that is under investigation itself,... Read More
Product Development

Downstream Effects of Inadequate Complaint Handling

Etienne Nichols
July 24, 2022
Getting a product to market is the number one goal of any MedTech startup. But the job isn’t over once that product is on the market—it’s just the beginning. Read More

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