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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Establishing a QMS

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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Establishing a QMS

Making the Business Case for an eQMS Solution for Your Company

Jeff Perkins
June 2, 2023
As a MedTech Quality professional, you know that you need an eQMS solution. Working in a legacy or paper-based system can significantly impact your team’s overall speed and... Read More
Product Development

Managing Major Changes to Medical Device Packaging

Etienne Nichols
May 29, 2023
Charles Darwin famously said, “It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change.”... Read More
Product Development

What is a Modern QMS?

Etienne Nichols
May 26, 2023
For medical device companies, the role of the quality management system (QMS) has greatly evolved—in both form and function. Read More
Establishing a QMS

2023 Greenlight Guru True Quality Roadshow: San Jose Recap

Greenlight Guru
May 24, 2023
Yes way, San Jose! On April 20th, the Greenlight Guru True Quality Roadshow landed in San Jose, California for its second stop of the 2023 tour. Unsurprisingly, the Bay Area... Read More
Product Development

4 Tips for Managing Your MedTech Portfolio

Etienne Nichols
May 24, 2023
There’s no doubt that MedTech is a noble industry, built on the mission of improving the quality of life with impactful medical devices. Read More
Product Development

The Risk Management + Design Controls Connection: What Device Makers Need to Know

Etienne Nichols
May 16, 2023
Medical devices are intended to save and improve quality of life. Read More
Product Development

How To Vet Medical Device Distributors in Multiple Markets

Ben Bancroft
May 15, 2023
The majority of medical device companies, even the relatively big ones, will need third-party distributors to get their devices to market. Read More
Product Development

What is the Best Way to Structure a Risk Management File?

Niki Price
May 14, 2023
The medical device risk management process relies heavily on the use of documentation. Whether the activity is conducted onsite or offsite, during design or after... Read More
Product Development

eIFU Requirements: Everything You Need to Know About Electronic Instructions for Use

Etienne Nichols
May 11, 2023
It doesn’t matter how well-engineered or high-quality your medical device is; you still need to make sure people know how to use it. Read More

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