Helping early-phase, fast-moving medical device companies & LDT service providers transition software development processes and documentation into an FDA-compliant state for IVD products.

Specialties:

• Software Quality support and process development
• Auditing for FDA 820 regulations and relevant ISO and IEC standards (BSI certified Lead auditor), including ISO 13485, ISO 14971, IEC 62034, IEC 27001, 21 CFR Part 11, 21 CFR 820.30, 21 CFR 820.70
• Biotechnology software management and SDLC process development
• Transitioning software organizations to FDA-compliant processes from RUO and LDT development practices
• Development & management of technology and innovation assessment processes
• QSR documentation for software and instrumentation & training

Recent engagements

• Assisted several class NGS (Next Generation Sequencing) human IVD and LDT startup companies in developing sustainable, FDA-compliant, and agile software development processes, including IEC 27001:2013 certification.
• Managed a program to deliver a factory-based workflow application for an NGS DNA Super-Sequencer.
• Helped an exciting and innovative IVD startup develop a best-of-class molecular diagnostic system. The company was purchased with an expansion in assay offerings and markets.
• Assisted a major biotechnology tools provider in developing a Manufacturing Execution System (MES) using industry standards and off-the-shelf tools. When complete, this program will deliver a highly configurable system that leverages the ISA88 process standards. This Recipe-based MES will allow a reduction in time to market from months to weeks, with no loss in quality, while improving traceability and reducing costs.