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Product Development

How are Medical Devices Classified under EU MDR?

May 1, 2024
One of the most important steps in bringing a medical device to market in the European Union (EU) is determining the correct classification for your device. Read More
Product Development

The Risk Management + Design Controls Connection: What Device Makers Need to Know

April 24, 2024
Medical devices are intended to save and improve quality of life. Read More
Establishing a QMS

Definitive Guide to Change Management for Medical Devices

April 22, 2024
In an industry that is ever-evolving, change is inevitable. Read More
Product Development

Quality Management Plan - How to Create Yours (Tips & Best Practices)

March 7, 2024
Technically speaking, you can launch a product without a quality management plan—but most of your go-to-market efforts will feel as though you’re shooting from the hip and... Read More
Product Development

How to Structure your Medical Device Technical File

March 5, 2024
The medical device technical file is a must-have document for devices to be sold in the EU marketplace. Read More
Product Development

Quality Assurance vs. Quality Control in the Medical Device Industry

March 1, 2024
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation... Read More
Establishing a QMS

ALM and Design Controls: Do SaMD and SiMD Manufacturers Need Both?

February 26, 2024
One consequence of the massive growth of software as a medical device (SaMD) and software in a medical device (SiMD) is the growing overlap between the realms of software... Read More
Establishing a QMS

How MHRA is Regulating Medical Devices in the UK after Brexit

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
Establishing a QMS

5 Habits of Highly Effective MedTech Companies

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

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