Technical Writing Portfolio
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Topics I Cover
FDA Compliance & Medical Device Regulations | Quality Management Systems (ISO 13485, QSR/QMSR) | ITAR, CMMC & Cybersecurity for Defense Contractors | Lean Manufacturing & Continuous Improvement | Documentation Best Practices | Supplier Quality Management.
5 Signs Your Quality Management System Needs Modernization
*Quality Management Systems | ISO 13485 | Digital Transformation | Lean Manufacturing*
FDA Compliance & Medical Device Regulations | Quality Management Systems (ISO 13485, QSR/QMSR) | CMMC & Cybersecurity for Defense Contractors | Lean Manufacturing & Continuous Improvement | Documentation Best Practices | Supplier Quality Management.
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The Hidden Cost of Poor Documentation in GMP Environments
*GMP Documentation | FDA Compliance | Quality Systems | ROI Analysis*
Poor documentation costs regulated companies an average of $150,000 annually—not in fines, but in wasted time, repeated investigations, and quality issues that compound over time. This piece quantifies the real costs: investigation time that doubles, defect rates that climb from 1.2% to 2.8%, customer complaints that escalate into $27K incidents, and audit findings that multiply. Includes a framework for implementing Good Documentation Practices with an 800% ROI.
CMMC Compliance for Medical Device Manufacturers: A Practical Guide
*CMMC | Cybersecurity | Defense Contractors | NIST 800-171 | Medical Devices*
Medical device manufacturers entering defense contracting face a hidden challenge: CMMC compliance. This guide breaks down the 110 NIST 800-171 controls, explains implementation costs ($50K-150K), identifies common pitfalls (scope creep, AI tool risks, documentation burden), and provides a practical roadmap. Written from the perspective of someone who's implemented both ISO 13485 and CMMC—because understanding how they intersect is critical.