The FDA is encouraging device manufacturers to sign up for the Voluntary Improvement Program, a joint initiative with industry designed to improve patient access to medical devices by maintaining product quality and limiting supply chain disruptions.
Gain expert insight into the collaborative Voluntary Improvement Program (and more!) with Making the Case for Device Quality Management — Insights from FDA and Industry Experts, a 2-plus hour compilation of key session highlights from the November 2023 GMP Quality Management vSummit. If you weren’t able to attend the Summit, presented by FDAnews, you won’t want to miss this!
Sessions include:
Making the Case for Quality – Voluntary Improvement Program
Francisco Vicenty, program manager for CDRH’s Case for Quality, along with representatives from the Medical Device Innovation Consortium and ISACA, discuss how device makers are using the collaborative Voluntary Improvement Program to achieve continuous improvement that advances performance and patient safety.
Updating Device Quality Regulations – What to Expect of the New QMSR
Kristen Grumet, senior vice president of regulatory compliance at Greenleaf Health, examines CDRH’s proposed revision to its Quality Systems Regulation and how the new rule incorporates the international quality standard, ISO 13485. She highlights the commonalities and differences between the current regulation and 13485 and provides insight into what can be expected once the proposed rule becomes a reality.
Quality Metrics – How Do You Measure Quality?
Understand the key performance indicators for a strong quality management system and what they can tell you about any gaps or problems in your system. This presentation, led by Pritesh Patel, president of PRP Consulting, considers the concept of measuring quality, as well as the metrics fit for that purpose.
The FDA is encouraging device manufacturers to sign up for the Voluntary Improvement Program, a joint initiative with industry designed to improve patient access to medical devices by maintaining product quality and limiting supply chain disruptions.
Gain expert insight into the collaborative Voluntary Improvement Program (and more!) with Making the Case for Device Quality Management — Insights from FDA and Industry Experts, a 2-plus hour compilation of key session highlights from the November 2023 GMP Quality Management vSummit. If you weren’t able to attend the Summit, presented by FDAnews, you won’t want to miss this!
Sessions include:
Making the Case for Quality – Voluntary Improvement Program
Francisco Vicenty, program manager for CDRH’s Case for Quality, along with representatives from the Medical Device Innovation Consortium and ISACA, discuss how device makers are using the collaborative Voluntary Improvement Program to achieve continuous improvement that advances performance and patient safety.
Updating Device Quality Regulations – What to Expect of the New QMSR
Kristen Grumet, senior vice president of regulatory compliance at Greenleaf Health, examines CDRH’s proposed revision to its Quality Systems Regulation and how the new rule incorporates the international quality standard, ISO 13485. She highlights the commonalities and differences between the current regulation and 13485 and provides insight into what can be expected once the proposed rule becomes a reality.
Quality Metrics – How Do You Measure Quality?
Understand the key performance indicators for a strong quality management system and what they can tell you about any gaps or problems in your system. This presentation, led by Pritesh Patel, president of PRP Consulting, considers the concept of measuring quality, as well as the metrics fit for that purpose.
The FDA is encouraging device manufacturers to sign up for the Voluntary Improvement Program, a joint initiative with industry designed to improve patient access to medical devices by maintaining product quality and limiting supply chain disruptions.
Gain expert insight into the collaborative Voluntary Improvement Program (and more!) with Making the Case for Device Quality Management — Insights from FDA and Industry Experts, a 2-plus hour compilation of key session highlights from the November 2023 GMP Quality Management vSummit. If you weren’t able to attend the Summit, presented by FDAnews, you won’t want to miss this!
Sessions include:
Making the Case for Quality – Voluntary Improvement Program
Francisco Vicenty, program manager for CDRH’s Case for Quality, along with representatives from the Medical Device Innovation Consortium and ISACA, discuss how device makers are using the collaborative Voluntary Improvement Program to achieve continuous improvement that advances performance and patient safety.
Updating Device Quality Regulations – What to Expect of the New QMSR
Kristen Grumet, senior vice president of regulatory compliance at Greenleaf Health, examines CDRH’s proposed revision to its Quality Systems Regulation and how the new rule incorporates the international quality standard, ISO 13485. She highlights the commonalities and differences between the current regulation and 13485 and provides insight into what can be expected once the proposed rule becomes a reality.
Quality Metrics – How Do You Measure Quality?
Understand the key performance indicators for a strong quality management system and what they can tell you about any gaps or problems in your system. This presentation, led by Pritesh Patel, president of PRP Consulting, considers the concept of measuring quality, as well as the metrics fit for that purpose.