V&V Activities from a Verification Engineer POV - How Hard Could It Be?

Global Medical Device Podcast powered by Greenlight Guru

What’s the difference between design verification and validation, and why are these activities so important?

Today’s guest is Niki Price. Niki is a Medical Device Guru with 15 years of experience in medical devices who worked in production, quality, product development, and project manager. Today she discusses questions like what is being tested by design verification and what is being tested by design validation.

Listen to the episode to hear Niki discuss what’s involved in being a verification engineer, tests used for verification, and the biggest challenges she experiences in her role.

Some of the highlights of this episode include:

• Niki’s background and experience
• The process involved in being a verification engineer
• The Greenlight Guru difference
• The steps that a verification engineer has to go through
• Tests used for verification
• Difficulties with the steps for verification
• The career path to design assurance professional
• The biggest challenges about this role
• Pitfalls of design verification

Memorable quotes from Niki Price:

“I wanted to be drawing body parts in an OR somewhere. Or illustrations in books.”

“The best time I ever had was sitting at my desk running through thousands of lines of data and trying to make charts out of it. I loved it.”

“Requirements are a lot of times going to be your acceptance criteria for your testing.”

“You have to think about verification is for design inputs, validation is for user needs.”

Links:

Niki Price LinkedIn

Etienne Nichols LinkedIn

Beginner's Guide to Design Verification & Design Validation for Medical Devices

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru