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Product Development

IQ, OQ, PQ: A Quick Guide to Process Validation

October 20, 2023
What is IQ, OQ, PQ? These are the abbreviations we use in the medical device industry for the three steps of process validation: Installation Qualification (IQ), Operational... Read More
Establishing a QMS

IVDR for In Vitro Diagnostic Medical Device Companies - Ultimate Guide

October 20, 2023
The global medical device industry is a space where forward thinking meets problem solving, all for the same purpose: to improve the quality of life. However, if you’re going... Read More
Establishing a QMS

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

October 20, 2023
On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulation (QMSR). Read More
Product Development

5 Foundational Steps of a CAPA Quality Process

October 19, 2023
I have a bold opinion: The corrective and preventive action (CAPA) process is the 2nd-most important component of your quality management system (QMS). Read More
Establishing a QMS

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

October 17, 2023
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Regulatory Submission

EU MDR - 9 Top Questions Answered (European MDR)

October 17, 2023
What is EU MDR? The European Medical Device Regulation (EU MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and... Read More
Regulatory Submission

MHRA Guidance Document on Clinical Investigations in UK

October 10, 2023
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the agency that regulates medical devices and in vitro diagnostics, as well as clinical... Read More
Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

October 2, 2023
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Product Development

Introducing The Greenlight Guru MedTech Suite: A Comprehensive Set Of Industry-Specific Solutions

September 18, 2023
Across the globe, visionaries and innovators are building the future of medical devices that improve the quality of life for millions of people. Read More

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