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

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Document Management Training Management CAPA Management Audit Management Product Development

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

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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Greenlight Guru Medical Device Blog

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

The Ugly Truth About Managing Design Controls on Spreadsheets

Etienne Nichols
November 20, 2023
At one point in my career, after managing the design controls and risk management documentation, I decided to move on. Read More
MedTech Lifecycle Excellence

Becoming an Advisor to a Medical Device Company

Etienne Nichols
November 16, 2023
In this episode, we delve into the multifaceted aspects of advisory roles within medical device startups. Read More
Establishing a QMS

Enterprise Quality Management Software: What You Need To Know

Etienne Nichols
November 14, 2023
A quality management system (QMS) is simply a formalized system for documents, policies, procedures, and processes that companies in many industries—including MedTech—use to... Read More
Regulatory Submission

Recent FDA Draft Guidances

Etienne Nichols
November 9, 2023
In this episode, we dissect the evolving landscape of FDA medical device regulations with regulatory expert Mike Drues. Read More
Product Development

Ultimate Guide to Supplier Management for Medical Device Companies

Ben Bancroft
November 8, 2023
A medical device is only as good as its parts. Read More
MedTech Lifecycle Excellence

The AI in MedTech Trend Report 2023 Is Here

Jeff Perkins
November 7, 2023
At Greenlight Guru, when we want to know exactly what’s happening in the MedTech industry, we like to go to the source: the medical device professionals who work every day to... Read More
MedTech Lifecycle Excellence

Greenlight Guru Releases The AI in MedTech Trend Report 2023

Greenlight Guru
November 7, 2023
The survey of more than 200 medical device professionals is a snapshot into the interest and attitudes toward AI tools and their adoption in the MedTech industry. Read More
Establishing a QMS

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

Jon Speer
November 3, 2023
The CAPA process is a frequent topic of discussion here at Greenlight Guru, mainly because it’s still such a big issue for medical device companies. Year after year, CAPA... Read More
Regulatory Submission

Planning an FDA Submission

Etienne Nichols
November 2, 2023
In this episode, Etienne Nichols and Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dive deep into the... Read More

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