Manufacturing
65 articles
Medical Device Process Validation: IQ, OQ, PQ, and the Complete Implementation Guide
Implement medical device process validation with IQ, OQ, and PQ methods, FDA and GHTF expectations, statistical tools, master plans, and continued process verification.
Medical Device Supply Chain Risk Management and Supplier Quality
Manage medical device supply chain risk with supplier qualification, risk assessment, dual sourcing, quality agreements, FDA and ISO 13485 controls, and resilience planning.
Sustainability & ESG in Medical Devices: Regulations and Best Practices
How sustainability, ESG reporting, and circular economy reshape medical device design, manufacturing, EU CSRD compliance, and lifecycle strategy.
Medical Device GMP: Manufacturing Requirements, FDA Inspections, and Compliance Guide
The complete guide to Good Manufacturing Practice for medical devices — 21 CFR 820, QMSR transition, process validation, FDA inspections, Form 483 observations, and practical compliance strategies.
Ethylene Oxide (EO) Sterilization for Medical Devices: The Complete Guide
A comprehensive guide to EO sterilization — process development, ISO 11135 validation, residuals testing, environmental compliance, and how it compares to alternative sterilization methods.