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About the Author

Based in Toronto, Canada, Alex Morris, MA, RAC, is a dedicated 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. He is versed in several standards and regulatory frameworks such as ISO 13485, EN ISO/ISO 14971, ISO 9001, ISO 27001, ISO 27002, IEC 62304, IEC 62366-1, IEC 60601-1 3rd Ed., ISO 14001, HIPAA, CMDR, 21 CFR Part 820 and MDD 93/42/EEC. Alex has assisted multiple MedTech companies succeed at using regulatory and quality as tools for driving compliance and profit. He founded and leads Frontline Health Consulting, a boutique consulting firm laser-focused on assisting small to medium-sized medical device companies achieve their quality, regulatory and information security goals. When he’s not assisting clients you can find him powering up dirt trails that hug the local escarpment on his trusty mountain bike. Alex is an ISO 9001 IRCA-certificated Lead Auditor and holds a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).

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