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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
Establishing a QMS

FDA Publishes Final Rule on QMSR

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
Establishing a QMS

Top Medical Device Conferences To Attend in 2024

February 2, 2024
Attending the right conference can be a game-changer for those working in the medical device industry. Read More
Product Development

Selecting a Notified Body: How to Work with Your New Device Authority

February 1, 2024
Before you can market your product in the European Union, medical device manufacturers must undergo a conformity assessment carried out by a Notified Body (NB) in order to... Read More
Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

January 3, 2024
Getting a medical device to market is a huge accomplishment for any MedTech company. Design and development, regulatory approval, supplier management and manufacturing,... Read More
Product Development

Most Popular Medical Device Content in 2023

December 15, 2023
2023 was a busy and exciting year here at Greenlight Guru. Over the past 12 months, we’ve been listening closely to our customers, innovating our products, and winning... Read More

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