Base in Toronto, Canada, Alex Morris, is a regulatory affairs and quality assurance consultant within the medical device industry. He designs, authors, implements and trains to 13485-compatible quality management systems. Regulatory and quality issues affecting software medical devices are his specialty. Morris is versed in ISO 13485, ISO 14971, ISO 9001, ISO 27001, ISO 27002, IEC 62304, IEC 62366-1, IEC 60601-13rd Ed., ISO 14001, HIPAA, CMDR, 21 CFR Part 820 and MDD93/42/EEC. Morris founded and leads Frontline Health Consulting that assists small to medium-sized medical device companies achieve their quality, regulatory, and information security goals.