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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

Top 3 Reasons for FDA 483 Observations in 2020 - Featured Image

Top 3 Reasons for FDA 483 Observations in 2020

The US Food and Drug Administration (FDA) has released the quality system inspection data for citati...
3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases - Featured Image

3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases

Too many companies still treat risk management as a “checkbox” activity.
Applying ISO 10993-1 to Medical Device Submission to FDA - Featured Image

Applying ISO 10993-1 to Medical Device Submission to FDA

ISO 10993-1 is the medical device industry’s globally recognized standard for biological evaluation ...
How the MDSAP Grading System Works - Featured Image

How the MDSAP Grading System Works

The Medical Device Single Audit Program (MDSAP) allows you to have a single audit of your medical de...
How to Make Your QMS Comply with EU MDR and IVDR - Featured Image

How to Make Your QMS Comply with EU MDR and IVDR

If your company has or is looking to place medical devices on the EU market, you need to know about ...
What is a Traceability Matrix and How Do I Create One for My Medical Device? - Featured Image

What is a Traceability Matrix and How Do I Create One for My Medical Device?

You’ve probably heard a traceability matrix is something you need as part of your medical device QMS...

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