Greenlight Guru Medical Device Blog

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Product Development

December 11, 2022

Ultimate Guide to Device Class Requirements under EU MDR

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Regulatory Submission

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

October 4, 2022

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Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson

July 17, 2022

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Product Development

Computer Systems Validation: How To Avoid FDA Warning Letters C.F.R. 820.70(i)

January 27, 2023

Computer systems validation (CSV) is a standard regulatory exercise Med Device companies are required to complete. This is not new news. Read More

Product Development

How to Collect PMCF Data for Lower-Class Medical Devices and WETs

Jon Bergsteinsson

January 27, 2023

Post-Market Clinical Follow-up (PMCF) is necessary for maintaining medical device regulatory compliance, and with the EU MDR, clinicians increasingly need to collect PMCF... Read More

MedTech Lifecycle Excellence

Essentials of Sterilization for Med Device Professionals

Etienne Nichols

January 25, 2023

What tools do sterilization engineers need the most? What’s the difference between sterilization modalities? Those are some of the points that our guest will be... Read More

MedTech Lifecycle Excellence

UDI: 101

Etienne Nichols

January 20, 2023

What is UDI? Why is it important, and what does the implementation of UDI look like? If you don’t know, you probably should start learning, and in today’s episode,... Read More

Product Development

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

January 20, 2023

IQ, OQ, and PQ are the abbreviations we use in the medical device industry for the three steps of process validation. Read More

Product Development

Understanding the 5 Phases of Medical Device Development

January 20, 2023

The purpose of any medical device is to benefit others and improve the quality of life. However, in order to keep patient and user risk at a minimum, authorities have... Read More

Product Development

How to Plan a Clinical Data Management Setup for EDC Systems

Páll Jóhannesson

January 20, 2023

When it comes to setting up forms and questionnaires for EDC systems, we’ve noticed a trend. Most are keen to get their study started but have not considered what it takes to... Read More

MedTech Lifecycle Excellence

Quality Myths and Lessons Learned

Etienne Nichols

January 18, 2023

What words cause the most problems in MedTech, and what situations should you be ready to handle when you work in Quality? Today’s guest wrote about these issues in... Read More

Establishing a QMS

Greenlight Guru Announces Partnership with Comply Guru

Etienne Nichols

January 17, 2023

Partnership will allow the medical device industry’s leading software platform to provide a wider range of courses in a variety of on-demand and blended learning formats. Read More

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