- Why Us
What would you think about dealing with complaints all day? Today’s guest has some ideas. Brittney McIver is a Medical Device Guru at Greenlight Guru where she helps guide companies through the various quality and regulatory requirements and challenges that are unique to MedTech companies and Medical Device Professionals - like QMS implementation. Brittney has a bachelor’s degree in Biological Science, a master’s degree in Bioengineering from Clemson University, and is an ISO 13485 Lead Auditor.
Listen to the episode to learn about Brittney’s experience shadowing doctors and watching surgery, the part of her job that involves handling complaints, and how complaints are related to post-market surveillance.
What effect does shadowing doctors and seeing surgeries have
The difficulties of a complaint handling role and how Brittney would structure the role in the company
Regulations around the complaint-handling process
Different streams that come into play as far as complaints go
Manufacturer employee complaints on social media
How complaints are related to post-market surveillance
Advice and recommendations for companies about complaints
“One of the things I wasn’t prepared for was the sheer volume of complaints sometimes.”
“You always look at a complaint and try to determine whether it is a complaint or not.”
“Any decision you’re making, you want to make sure that it’s informed and you have a rationale behind it.”
“One of the things that you don’t want to happen is your customer not report the complaint to you, but they report it to the FDA.”
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
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...