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

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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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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

How MHRA is Regulating Medical Devices in the UK after Brexit

Wade Schroeder
February 22, 2024
If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in the regulatory landscape resulting from Brexit are relevant to you. Read More
Post-Market Surveillance

Investigator Initiated Studies — 3 Common Problems and How to Fix Them

Chris Rush
February 22, 2024
An investigator initiated study (IIS) is a clinical trial of a device that is sponsored by an independent researcher, rather than the manufacturer of the device. The clinical... Read More
Establishing a QMS

5 Habits of Highly Effective MedTech Companies

Tory Lopez
February 20, 2024
At Greenlight Guru, our annual State of the MedTech Industry Report offers a comprehensive view of our industry and the opinions and outlook of more than 500 MedTech... Read More
MedTech Lifecycle Excellence

Mastering the Pitch: MedTech Innovations from Concept to Market

Etienne Nichols
February 20, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols dives into the art of pitching to medical device investors with Blythe Karow, COO at Neurogeneces. Read More
MedTech Lifecycle Excellence

How to Use the Turtle Diagram for Better Internal Audits

Jamie Bihary
February 9, 2024
An internal audit can be an overwhelming prospect, especially if you’re new to the company or internal auditing in general. Read More
MedTech Lifecycle Excellence

Greenlight Guru Announces the 2024 True Quality Roadshow

Kennedy Gennari
February 9, 2024
The free MedTech event series will make stops in four cities, including an international event in Europe. Read More
MedTech Lifecycle Excellence

Becoming a MedTech Regulatory Affairs Professional

Etienne Nichols
February 7, 2024
In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory... Read More
Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
On January 31st, 2024, FDA issued their final rule amending the Quality System Regulation (QSR) to better align with ISO 13485:2016, the international standard for quality... Read More
MedTech Lifecycle Excellence

Calculating Nonconformance Costs in the MedTech Industry

Etienne Nichols
February 2, 2024
In the MedTech industry, nonconformance costs are about more than just your company’s bottom line. Read More

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