What would you think about dealing with complaints all day? Today\u2019s 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\u2019s degree in Biological Science, a master\u2019s degree in Bioengineering from Clemson University, and is an ISO 13485 Lead Auditor.
Listen to the episode to learn about Brittney\u2019s experience shadowing doctors and watching surgery, the part of her job that involves handling complaints, and how complaints are related to post-market surveillance.
\u201cOne of the things I wasn\u2019t prepared for was the sheer volume of complaints sometimes.\u201d
\u201cYou always look at a complaint and try to determine whether it is a complaint or not.\u201d
\u201cAny decision you\u2019re making, you want to make sure that it\u2019s informed and you have a rationale behind it.\u201d
\u201cOne of the things that you don\u2019t want to happen is your customer not report the complaint to you, but they report it to the FDA.\u201d