Michael C. Sieve

Working with Life Science companies to help improve Product Development Processes. Consulted with over 100 companies to improve product development processes focusing on requirements, testing, and issue management procedures with an objective to improve quality, compliance, and time to market.

A certified SixSigma Master Black Belt and MBA for Life Sciences Professional Services. With over 10 years in compliance industries including: life science, government, and utilities.

Well versed in Risk Management/Mitigation, FMEA, SixSigma and LEAN techniques for improving, implementing, and automating business processes to exceed regulations and expectations, while reducing costs. Led 20+ and Managed 50+ Six Sigma Projects focusing on minimizing risk, defects, and time to market using both human and electronic enforcement controls.

Certified Master Black Belt in Lean Six Sigma, Software Validation, Risk Management, and Negotiation. Well versed in the General Principles of Software Validation, ISO 13485 & 62304 and Part 11 Compliance.