MethodSense, Inc.
Personal Information
Organization / Workplace
MethodSense, Inc.Location
Raleigh-Durham, North Carolina Area United StatesOccupation
Medical Device Quality and Regulatory Consultant at MethodSense, Inc.Industry
Medical / Health Care / Pharmaceuticals
Website
www.methodsense.comAbout
I'm the president and managing partner of MethodSense, a life science consulting firm with offices in the US and Europe. We guide medical device, biotech and pharmaceutical companies with quality, regulatory and technology solutions. Our guidance enables clients to operate more effectively during the commercialization process and beyond. MethodSense delivers FDA submission support and compliance strategies, quality system development, process and validation strategies and execution, vendor and internal audits, software development methodology optimization, software design control evaluations, risk remediation and GxP, 21 CFR Part 11, ISO, NTLA, HIPAA, CMM expertise. My expertise spans