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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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Post-Market Surveillance

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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Product Development

How To Approach Supplier Corrective Action Requests (SCAR)

Taylor Brown
September 15, 2023
For medical device manufacturers, finding success means setting ourselves up for success with repeatable processes that not only ensure quality, but also mitigate future risk. Read More
Product Development

Engineering Change Order: Its Role in the Change Management Process

Jesseca Lyons
September 14, 2023
Change is just part of life for medical device companies. No device makes it to market without quite a few changes to its design along the way, and even devices already on... Read More
Post-Market Surveillance

How to Structure a Clinical Investigation Report (CIR) Summary

Stephanie Hinton
September 8, 2023
If you’re conducting a clinical investigation of a medical device in an EU Member State, you will be required to submit a clinical investigation report (CIR) along with a... Read More
Post-Market Surveillance

How to Comply with HIPAA and EU GDPR in Medical Device Studies

Chris Rush
August 17, 2023
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the US and the EU have regulations in place... Read More
Post-Market Surveillance

Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting

Páll Jóhannesson
August 4, 2023
The latest Greenlight Guru Clinical update includes a newly designed Reporting module that streamlines clinical data management for scaling medical device companies. By... Read More
Product Development

How to Improve Detecting, Correcting, and Preventing Nonconformances

Etienne Nichols
July 17, 2023
If you work at a MedTech company, nonconformances are a fact of life. As long as there is still a human element in the development and manufacture of medical devices, there... Read More
Establishing a QMS

eQMS Buyer’s Guide: Making the Business Case for a New QMS Solution

Etienne Nichols
July 6, 2023
You know you need a new QMS solution. You may even have your sights set on an eQMS that you’ve evaluated and believe is the best option for your organization. Read More
Product Development

Identifying and Evaluating Medical Device Importers

Etienne Nichols
July 3, 2023
Expanding into new foreign markets is an exciting chapter for any medical device manufacturer. Read More
Product Development

How to Develop a Risk-Based Approach to Supplier Management

Etienne Nichols
June 18, 2023
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your... Read More

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