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Data collection and management designed for MedTech clinical trials.

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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.
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Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
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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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Establishing a QMS

Top Medical Device Conferences To Attend in 2024

Kennedy Gennari
February 3, 2023
Attending the right conference can be a game-changer for those working in the medical device industry. Read More
Product Development

Process Verification vs Process Validation: What’s the Difference?

Etienne Nichols
February 3, 2023
In a highly regulated industry like MedTech, manufacturing processes must undergo either process verification or process validation to ensure they’re consistently producing... Read More
Product Development

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

Sara Adams
February 1, 2023
The Periodic Safety Update Report (PSUR) is one of the new postmarket surveillance (PMS) activities required by EU MDR and EU IVDR. These new regulations represent a complete... Read More
Establishing a QMS

Greenlight Guru Announces 2023 True Quality Roadshow

Greenlight Guru
February 1, 2023
The free MedTech event series will make stops in six cities, including one international date. Read More
Establishing a QMS

What is 21 CFR 812 - Investigational Device Exemption?

Etienne Nichols
February 1, 2023
Could your medical device qualify for an investigational device exemption (IDE) under 21 CFR 812? Read More
Establishing a QMS

Greenlight Guru Releases 2023 MedTech Industry Benchmark Report

Greenlight Guru
January 30, 2023
Topics include the challenges of bringing products to market, analysis of current market opportunities and projections for the MedTech industry. Read More
Product Development

Computer Systems Validation: How To Avoid FDA Warning Letters C.F.R. 820.70(i)

Chris McHale
January 27, 2023
Computer systems validation (CSV) is a standard regulatory exercise Med Device companies are required to complete. This is not new news. Read More
Product Development

Understanding the 5 Phases of Medical Device Development

Adnan Ashfaq
January 20, 2023
The purpose of any medical device is to benefit others and improve the quality of life. However, in order to keep patient and user risk at a minimum, authorities have... Read More
Establishing a QMS

Greenlight Guru Announces Partnership with Comply Guru

Etienne Nichols
January 17, 2023
Partnership will allow the medical device industry’s leading software platform to provide a wider range of courses in a variety of on-demand and blended learning formats. Read More

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