MethodSense, Inc.

15 Seguidores

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

methodsense medical device basic safety medical device approval medical device consultants medical device software medical devices 21 cfr part 11 iec 62304 fda compliance quality management systems 21 cfr part 820 medical device essential performance software development life cycle iec 60601-1 medical device compliance infostrength iso 13485 infographic 510(k) clearance fda approval qms gmp 510(k) fda software validation medical device design essential performance for medical devices business strategy risk management iso 14975 regulatory affairs pre-market approval pre-market notification

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MethodSense, Inc.

Apresentações

FDA Regulations and Medical Device Pathways to Market

FDA Regulations and Medical Device Pathways to Market

IEC 62304: SDLC Conformance and Management

Documentos

Understanding IEC 62304

Infográficos

IEC 62304 Action List