Meet a Guru: Jamie Bihary

In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Jamie Bihary, a Medical Device Guru at Greenlight Guru.

Jamie shares her journey from biomedical engineering to her current role, where she helps companies transition from legacy quality management systems (QMS) to cutting-edge electronic QMS (eQMS). They discuss the common challenges faced during these transitions, the importance of environmental monitoring in clean rooms, and practical advice for managing QMS implementations.

Jamie also highlights the value of Greenlight Guru’s resources, including their robust partner network and support systems.

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Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Key Timestamps

• 00:00 - 02:00 Introduction and Jamie Bihary’s background
• 02:01 - 05:30 A day in the life of a Medical Device Guru at Greenlight Guru
• 05:31 - 10:15 Common challenges faced by new MedTech companies
• 10:16 - 15:00 Jamie’s journey from biomedical engineering to Greenlight Guru
• 15:01 - 20:30 Implementing EQMS and document migration process
• 20:31 - 25:45 Importance of environmental monitoring in clean rooms
• 25:46 - 30:10 Transitioning from legacy systems to EQMS
• 30:11 - 35:00 The value of internal audits and giving/receiving feedback
• 35:01 - 40:15 Greenlight Guru’s partner and alliance network
• 40:16 - 45:00 Key advice for companies starting or transitioning QMS

Key Takeaways

1. Transitioning from legacy QMS to EQMS can significantly streamline quality management processes and enhance efficiency.
2. Internal audits and open communication are vital for continuous improvement and compliance in the MedTech industry.

Practical Tips for MedTech Professionals

1. Establish a detailed implementation plan for QMS transitions to ensure a clear and documented process.
2. Utilize the resources and support offered by partners and consultants to manage workload and expertise gaps.
3. Regularly conduct internal audits and encourage a culture of feedback to identify and rectify potential issues early.

Links

• Greenlight Guru: Learn more about their EQMS solutions and support network.
• FDA Database: Reference for regulatory guidelines and compliance.
• LinkedIn Profile of Jamie Bihary: Connect with Jamie for more insights and support.

Memorable quotes

• "Our system had done really well with past audits, so it was crucial that we made the transition smoothly and accurately." – Jamie Bihary
• "Everyone in your organization impacts product quality in some capacity." – Jamie Bihary

Feedback

Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

About the Global Medical Device Podcast:

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.

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