Helping early-phase, fast-moving medical device companies transition software development processes and documentation into an FDA-compliant state.
- Software Quality support and process development
- Auditing for FDA 820 regulations and relevant ISO standards
- Biotechnology software management and SDLC process development
- Transitioning software organizations to FDA-compliant processes
- Development & management of technology and innovation assessment processes
- QSR documentation for software and instrumentation
- Assisted several class NGS (Next Generation Sequencing) human diagnostic startups develop a sustainable, FDA compliant, and agile software development process.
- Managed a program to deliver a factory-based workflow application for a NGS DNA Super-Sequencer.
- Helped an exciting and innovative IVD startup develop a best-of-class molecular diagnostic system. the company was recently purchased with an expansion in assay offerings and markets
- Assisted a major biotechnology tools provider to develop 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 allows a reduction in time to market from months to weeks, with no loss in quality, while improving traceability and reducing costs.