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Posts by Alex Morris

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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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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Establishing a QMS

Best Document Management Practices for Medical Device Startups: Don’t Cheap Out

Alex Morris
February 4, 2016
Vendor-supplied document management systems have loads of advantages that even the youngest startup can appreciate. They can be configured to automate most if not all of... Read More

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