Artwork

Greenlight Guru + Medical Device Entrepreneurs द्वारा प्रदान की गई सामग्री. एपिसोड, ग्राफिक्स और पॉडकास्ट विवरण सहित सभी पॉडकास्ट सामग्री Greenlight Guru + Medical Device Entrepreneurs या उनके पॉडकास्ट प्लेटफ़ॉर्म पार्टनर द्वारा सीधे अपलोड और प्रदान की जाती है। यदि आपको लगता है कि कोई आपकी अनुमति के बिना आपके कॉपीराइट किए गए कार्य का उपयोग कर रहा है, तो आप यहां बताई गई प्रक्रिया का पालन कर सकते हैं https://hi.player.fm/legal
Player FM - पॉडकास्ट ऐप
Player FM ऐप के साथ ऑफ़लाइन जाएं!

#370: Meet a Guru: Jamie Bihary

32:27
 
साझा करें
 

Manage episode 421935092 series 3504807
Greenlight Guru + Medical Device Entrepreneurs द्वारा प्रदान की गई सामग्री. एपिसोड, ग्राफिक्स और पॉडकास्ट विवरण सहित सभी पॉडकास्ट सामग्री Greenlight Guru + Medical Device Entrepreneurs या उनके पॉडकास्ट प्लेटफ़ॉर्म पार्टनर द्वारा सीधे अपलोड और प्रदान की जाती है। यदि आपको लगता है कि कोई आपकी अनुमति के बिना आपके कॉपीराइट किए गए कार्य का उपयोग कर रहा है, तो आप यहां बताई गई प्रक्रिया का पालन कर सकते हैं https://hi.player.fm/legal

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:


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 podcast@greenlight.guru.

Feedback:

We’d love to hear your feedback on this episode! Please leave a review on iTunes and share your suggestions for future topics. Email us at podcast@greenlight.guru.

Sponsors:

Greenlight Guru: Elevate your QMS with Greenlight Guru’s cutting-edge EQMS solutions, designed specifically for the MedTech industry. Visit Greenlight Guru to learn more and take advantage of special offers for our listeners.

  continue reading

350 एपिसोडस

Artwork
iconसाझा करें
 
Manage episode 421935092 series 3504807
Greenlight Guru + Medical Device Entrepreneurs द्वारा प्रदान की गई सामग्री. एपिसोड, ग्राफिक्स और पॉडकास्ट विवरण सहित सभी पॉडकास्ट सामग्री Greenlight Guru + Medical Device Entrepreneurs या उनके पॉडकास्ट प्लेटफ़ॉर्म पार्टनर द्वारा सीधे अपलोड और प्रदान की जाती है। यदि आपको लगता है कि कोई आपकी अनुमति के बिना आपके कॉपीराइट किए गए कार्य का उपयोग कर रहा है, तो आप यहां बताई गई प्रक्रिया का पालन कर सकते हैं https://hi.player.fm/legal

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:


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 podcast@greenlight.guru.

Feedback:

We’d love to hear your feedback on this episode! Please leave a review on iTunes and share your suggestions for future topics. Email us at podcast@greenlight.guru.

Sponsors:

Greenlight Guru: Elevate your QMS with Greenlight Guru’s cutting-edge EQMS solutions, designed specifically for the MedTech industry. Visit Greenlight Guru to learn more and take advantage of special offers for our listeners.

  continue reading

350 एपिसोडस

Усі епізоди

×
 
Loading …

प्लेयर एफएम में आपका स्वागत है!

प्लेयर एफएम वेब को स्कैन कर रहा है उच्च गुणवत्ता वाले पॉडकास्ट आप के आनंद लेंने के लिए अभी। यह सबसे अच्छा पॉडकास्ट एप्प है और यह Android, iPhone और वेब पर काम करता है। उपकरणों में सदस्यता को सिंक करने के लिए साइनअप करें।

 

त्वरित संदर्भ मार्गदर्शिका