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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
Post-Market Surveillance

Electronic Data Capture (EDC) Buyer’s Guide: Making the Business Case for a New EDC System

December 6, 2023
Whether you’ve got a new clinical trial on the horizon, or you’re just fed up with the limitations of the way you’re currently capturing clinical data, you’ve probably got a... Read More
Regulatory Submission

Recent FDA Draft Guidances

November 9, 2023
In this episode, we dissect the evolving landscape of FDA medical device regulations with regulatory expert Mike Drues. Read More
Product Development

Ultimate Guide to Supplier Management for Medical Device Companies

November 8, 2023
A medical device is only as good as its parts. Read More
Regulatory Submission

Planning an FDA Submission

November 2, 2023
In this episode, Etienne Nichols and Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dive deep into the... Read More
Product Development

Ultimate Guide to Software as a Medical Device (SaMD)

October 30, 2023
Only recently has the medical device industry began designing software-based products that have no direct relationship to hardware devices at all. Read More
Product Development

Ultimate Internal Audit Checklist: FDA QSR & ISO 13485 Audit Checklist

October 25, 2023
It was nothing more than a checklist that saved $175 million and 1,500 lives. Read More
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

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