Description

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.

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

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

Takeaways:

Key Insights:

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:

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.

Future Questions:

1. How can smaller MedTech companies best leverage partnerships to stay competitive?

References:

• 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.

MedTech 101:

Quality Management System (QMS): A QMS is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct an organization's activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

Electronic Quality Management System (EQMS): An EQMS is a digital version of a QMS, offering automated processes, real-time data access, and integration with other enterprise systems to enhance compliance, efficiency, and overall quality management.

Questions for the Audience:

• Poll: What is the biggest challenge you face when transitioning from a legacy QMS to an EQMS? Email us your answers at