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From Successful LinkedIn Professional Quality Network Group to QMS Consulting Company

Boston, MA – July 6, 2016 –  Announced a successful launch of a new company, Quality & Regulatory Network LLC, to help FDA-regulated companies consolidate and harmonize their Quality Management System enterprise-wide.  MORE

FDA CDRH Benefit-Risk Guidance: Industry Survey

Boston, MA - March 28, 2017 - Nikki Willett, Founder and Principal Consultant at Quality & Regulatory Consulting LLC, presented results from an Industry Survey about the Final Guidance on Benefit-Risk Considerations for Medical Devices at the recent  FDAnews Medical Device Quality Congress in Bethesda, Maryland. Along with key members from FDA CDRH such as Robin Newman, Director, Office of Compliance, Ann Ferriter, Director, Division of Analysis and Program Operations, OC, and Ron Brown, Recall Branch, the panel focused on key factors and benefits of real world evidence and device benefit-risk data and calculations for use in enforcement discretion following post-market inspections. The Industry included ten questions about the impact of the Guidance set in an unbiased and safe harbor forum for the Industry to provide feeback to the FDA. General comments were positove. The Industry's main concerns were about the details of how the FDA intends to implement the Guidance with a vast and diverse amount of medical devices and also were concerned about the reliability of data including those coming from Patient Preference (PPI).  The Survey is still open to continue to collect more data from industry. To participate please use the following URL: 

https://www.surveymonkey.com/r/benefit-risk