Episode Description
What’s it like to become a Medical Device Guru? In today’s episode, you’ll meet one of our newer Gurus, Brittani Smith, and find out more about her role and journey working through UDI implementation, EU MDR preparation, and finding her place in a MedTech company.
Brittani is a Medical Device Guru at Greenlight Guru. Our Medical Device Gurus are part of what we call the Guru Edge here at Greenlight Guru. As a Medical Device Guru, Brittney helps guide companies through the various Quality and regulatory requirements and challenges that are unique to MedTech companies and Medical Device Professionals.
Listen to this episode to hear Brittani talk about the challenges of working through UDI & EU MDR implementation, the resources that helped her learn more about regulatory and quality, and what a day in the life of a Guru entails.
Some of the highlights of this episode include:
- Resources that Brittani uses everyday in regulatory and quality
- How to identify a company's power centers and knowledge in a company and building social capital
- Common pitfalls Brittani sees during implementation
- Examples of things people don’t think to document
- Having knowledge dismissed due to youth
- Consistent questions MedTech professionals see
Memorable quotes from Brittani Smith:
“I was in every audit that we were a part of from when I started to when I left the company, so audits are my jam.”
“Everyone in regulatory is learning it on the job.”
“I wasn’t afraid to be wrong, but I didn’t want to be wrong because I didn’t have the right resources.”
“I think the simplest answer is I’d love to manage people.”
Links:
The Essential Guide to Preparing your QMS for EU MDR
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