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
Contact Details
Tags
methodsensemedical device consultantsmedical device approval21 cfr part 11medical device basic safetymedical devicesmedical device softwarefda complianceiec 62304quality management systems21 cfr part 820gmpqmsfda approval510(k) clearanceinfographic510(k)fdaiso 13485infostrengthmedical device complianceiec 60601-1software development life cyclemedical device essential performancepre-market notificationpre-market approvalregulatory affairsiso 14975risk managementbusiness strategyessential performance for medical devicesmedical device designsoftware validation
We鈥檝e updated our privacy policy so that we are compliant with changing global privacy regulations and to provide you with insight into the limited ways in which we use your data.
You can read the details below. By accepting, you agree to the updated privacy policy.
