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Etienne Nichols

Etienne Nichols
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Author's Posts

How to Build a Medical Device Business Case in 5 Easy Steps - Featured Image

How to Build a Medical Device Business Case in 5 Easy Steps

In business, so much of success depends on timing. A product launches too early and is misunderstood...
Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance - Featured Image

Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance

A Performance Evaluation (PE) is required for any in vitro diagnostic device (IVD) that a manufactur...
30/60/90 Day Plan to Making an Impact as a New QA/RA Manager - Featured Image

30/60/90 Day Plan to Making an Impact as a New QA/RA Manager

Starting a new job is always a little stressful. But when you’re a new QA/RA Manager, there’s even m...
Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities - Featured Image

Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities

The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipul...
3 Tips for Planning a Successful Product Development Project for Your Medical Device - Featured Image

3 Tips for Planning a Successful Product Development Project for Your Medical Device

If you’ve ever been involved in the design and development of a medical device, you know just how co...
Explaining UDI Requirements for GUDID and EUDAMED - Featured Image

Explaining UDI Requirements for GUDID and EUDAMED

Recent numbers from the World Health Organization indicate there are at least 2 million different ty...
30/60/90 Day Plan to Making an Impact as a Product Development Engineer - Featured Image

30/60/90 Day Plan to Making an Impact as a Product Development Engineer

To say product development engineers are important to medical device development would be the unders...
3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
Let The Document Tell The Story: Document Management Best Practices - Featured Image

Let The Document Tell The Story: Document Management Best Practices

Good stories follow a 3-act structure: Act 1: Set up Act 2: Conflict Act 3: Resolution “Thanks a lot...
QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies - Featured Image

QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...
ISO 11137: An Introduction to Gamma Sterilization Validation - Featured Image

ISO 11137: An Introduction to Gamma Sterilization Validation

For many medical device companies, sterilization is one of the final hurdles they have to clear befo...
Best Practices for an Effective Medical Device Design Transfer Process - Featured Image

Best Practices for an Effective Medical Device Design Transfer Process

If you’re looking for information on design controls and product development, you can find a practic...

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