Complaint Handling with Medical Device Guru, Brittney McIver

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.

Some of the highlights of this episode include:

• 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

Memorable quotes from Brittney McIver:

“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.”

Links:

Brittney McIver

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Greenlight Guru Academy

Greenlight Guru