Al Pacheco is an expert in the field of medical device design controls with over 16 years' experience in FDA-regulated product development with over 10 of these years as a technical manager responsible for hardware/software verification and validation. Al has extensive international experience working with companies in establishing compliance with design controls to achieve 510(k) clearance. He has authored design control procedures and established design history files for over 50 medical device product releases and has authored content for numerous 510(k) submissions.
Al has also authored a range of FDA & ISO compliant quality systems procedures for the FDA QSR, ISO 13485, ISO 14971 and IEC 62304. He has extensive experience in compliance audits, performing gap analyses, and implementing best practices for achieving FDA design control compliance. Consulting style integrates extensive technical and managerial product development experience with practical, proven practices in establishing compliance with FDA & ISO regulations.