Manufacturing
57 articles
Bioburden Testing for Medical Devices: Complete ISO 11737-1 Guide
Guide to bioburden testing under ISO 11737-1:2018, covering method validation, recovery efficiency, extraction, enumeration, dose setting, and routine monitoring for medical device sterilization.
Cleanroom Standards for Medical Devices: Complete ISO 14644 Guide
Classify, design, validate, and monitor ISO 14644 cleanrooms for medical devices, including particle limits, environmental monitoring, FDA/EU GMP expectations, and 2025 updates.
Cost of Quality in Medical Devices: Prevention, Appraisal, and Failure Costs
How to calculate and reduce medical device Cost of Quality using prevention, appraisal, internal failure, and external failure categories aligned with ISO 13485 and FDA QMSR.
Equipment Calibration Management for Medical Devices: ISO 13485 Clause 7.6 Complete Guide
Guide to medical device equipment calibration management under ISO 13485 Clause 7.6 and FDA QMSR, covering traceability, schedules, out-of-tolerance handling, records, and software tools.
FDA Establishment Registration & Device Listing: Complete Compliance Guide
Guide to FDA establishment registration and device listing under 21 CFR Part 807, including FURLS/DRLM, FY 2026 fees, who must register, annual renewal, and common violations.
GMP vs cGMP for Medical Devices Under FDA QMSR
Understand GMP and cGMP expectations for device manufacturing under FDA QMSR, 21 CFR Part 820, ISO 13485, design controls, production, labeling, and inspections.
ISO 11137 Radiation Sterilization: Gamma, E-Beam, and X-Ray Guide
Guide to ISO 11137 radiation sterilization for medical devices, covering gamma, e-beam, and X-ray methods, dose establishment, materials compatibility, validation, and dose audits.
ISO 17665 Steam Sterilization Guide for Medical Devices
Guide to ISO 17665 steam sterilization, covering moist heat principles, IQ/OQ/PQ validation, F0 lethality, biological indicators, cycle design, autoclave qualification, and monitoring.
QA vs QC in Medical Devices: Roles, Responsibilities, and QMSR Impact
Compare QA and QC in medical device manufacturing, including process vs product focus, team roles, tools, organizational structure, and QMSR alignment.
3D Printed Medical Devices: FDA, EU MDR Regulatory Guide (2026)
Regulatory guide to 3D printed medical devices, covering FDA pathways, EU MDR classification, patient-matched devices, point-of-care printing, process validation, and key standards.
Brazil ANVISA Medical Device Cost Breakdown: Fees and Add-Ons (2026)
2026 Brazil ANVISA device cost guide with government fees by class, BGMP audit costs, MDSAP carve-outs, ANATEL and INMETRO add-ons, and Brazilian Registration Holder retainers.
KGMP Certification for Foreign Manufacturers: 2026 Requirements and Process
Guide to KGMP certification for foreign medical device manufacturers, covering MFDS requirements, document preparation, audit types, costs, timelines, and 2026 GMP updates.
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.