Manufacturing
25 articles
Medical Device Process Validation: IQ, OQ, PQ, and the Complete Implementation Guide
A comprehensive guide to process validation for medical devices — covering IQ, OQ, PQ methodology, FDA and GHTF requirements, statistical tools, validation master plans, and continued process verification.
Medical Device Supply Chain Risk Management: The Complete Guide to Resilience, Compliance, and Supplier Quality
A comprehensive guide to medical device supply chain management — from supplier qualification and risk assessment to dual sourcing, quality agreements, and building supply chain resilience under FDA and ISO 13485.
Sustainability & ESG in Medical Devices: Regulatory Drivers, Circular Economy, and Industry Best Practices
How environmental sustainability, ESG reporting, and circular economy principles are transforming medical device design, manufacturing, and regulation — covering EU CSRD, FDA green initiatives, lifecycle assessment, and practical implementation strategies.
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.