Manufacturing
25 articles
EPA Ethylene Oxide Emissions Regulations for Medical Device Sterilization: 2026 Proposed Rollback, Compliance, and Supply Chain Impact
How the EPA's 2026 proposed rollback of ethylene oxide emissions standards affects medical device manufacturers, sterilization facilities, and supply chains — the 2024 rule, proposed changes, compliance timelines, and alternative sterilization strategies.
Medical Device CDMO Market 2026: $354B by 2033, Key Players, and Strategic Outsourcing Guide
The medical device CDMO market is projected to grow from $134.65 billion in 2025 to $354.60 billion by 2033 at 13.12% CAGR. This guide covers market size, growth drivers, key players (Jabil, Integer, Flex, Plexus), M&A trends, and how to choose the right contract manufacturing partner.
ASTM D4169 Transportation Validation for Medical Device Packaging: Distribution Simulation, Distribution Cycles, Assurance Levels, and Acceptance Criteria
Complete guide to ASTM D4169 performance testing for medical device packaging — distribution cycle selection (DC-13, DC-6, DC-12), assurance levels (I, II, III), test schedules (drop, compression, vibration, low pressure, impact), pre-conditioning per ASTM D4332, relationship to ISO 11607 sterile barrier validation, FDA 510(k) requirements, sample size justification, acceptance criteria development, common pitfalls, and step-by-step implementation guide.
Medical Device Contract Manufacturing (CMO) Selection and Quality Agreements: Complete Guide
How to select a medical device contract manufacturing organization — CMO evaluation criteria, quality agreement requirements under FDA 21 CFR 820 and ISO 13485, audit programs, change control, and step-by-step implementation checklist.
Design Transfer to Manufacturing for Medical Devices: DMR Readiness, Process Validation, and Supplier Handoff
Complete guide to medical device design transfer — how to move from design to production under FDA 21 CFR 820.30(h), ISO 13485 Clause 7.3.8, and QMSR. Covers DMR readiness, process validation (IQ/OQ/PQ), supplier qualification, and audit-ready documentation.
Environmental Compliance for Medical Devices: RoHS, REACH, WEEE, and Global Regulatory Guide
Complete guide to environmental regulations for medical devices — EU RoHS restricted substances and exemptions, REACH SVHC obligations and SCIP database, WEEE producer responsibilities, global RoHS adoption in China/Korea/Saudi Arabia, and manufacturer compliance strategies in 2026.
Endotoxin and Pyrogen Testing for Medical Devices: Complete BET Guide (ISO 11737-3, USP <85>, FDA 2026)
How to perform bacterial endotoxin testing (BET) for medical devices — LAL gel-clot, chromogenic, and turbidimetric methods, recombinant Factor C (rFC), USP <85>/<161>, ISO 11737-3, FDA 2026 pyrogen guidance update, endotoxin limits by device type, method selection, and regulatory submissions.
Batch Records for Medical Devices: Complete Guide to BMR, EBR, and DHR — Paper vs Electronic, 21 CFR 210/211 Compliance, and FDA QMSR Requirements
Master batch manufacturing records (BMR), electronic batch records (EBR), and device history records (DHR) for medical device manufacturing. Covers 21 CFR 210/211, 21 CFR Part 820/QMSR, ISO 13485, paper vs electronic systems, review workflows, deviation management, and FDA inspection readiness.
Bioburden Testing for Medical Devices: Complete ISO 11737-1 Guide
How to perform bioburden testing for medical devices under ISO 11737-1:2018 — method validation, recovery efficiency, extraction techniques, enumeration methods, dose setting, and routine monitoring for sterilization validation.
Cleanroom Standards for Medical Devices: Complete ISO 14644 Guide
How to classify, design, validate, and monitor cleanrooms for medical device manufacturing under ISO 14644 — particle count limits, classification methodology, environmental monitoring programs, FDA and EU GMP requirements, and the 2025 update to ISO 14644-5.
Cost of Quality (CoQ) in Medical Devices: Complete Framework — Prevention, Appraisal, Internal & External Failure Costs
How to calculate and reduce Cost of Quality in medical device manufacturing using the four-category model. Includes the 1-10-100 rule, McKinsey industry benchmarks (6.8–9.4% of sales), eQMS ROI data, and step-by-step implementation aligned with ISO 13485 and FDA QMSR.
Equipment Calibration Management for Medical Devices: ISO 13485 Clause 7.6 Complete Guide
How to build and manage an equipment calibration program for medical device manufacturing — ISO 13485 Clause 7.6 requirements, FDA QMSR compliance, NIST traceability, ISO 17025 accreditation, calibration schedules, out-of-tolerance procedures, and electronic calibration management.
FDA Establishment Registration & Device Listing: Complete Compliance Guide
Comprehensive guide to FDA medical device establishment registration and device listing under 21 CFR Part 807 — FURLS/DRLM system walkthrough, FY 2026 fees ($11,423), who must register, annual renewal process, common violations, and step-by-step instructions.
GMP vs cGMP for Medical Devices: Complete Guide to Current Good Manufacturing Practice Under FDA QMSR (21 CFR 820)
Understand the difference between GMP and cGMP for medical device manufacturing. Covers FDA QMSR (effective Feb 2026), 21 CFR Part 820, ISO 13485:2016 harmonization, cGMP requirements for design controls, production, packaging, labeling, and FDA inspection readiness.
Radiation Sterilization for Medical Devices (ISO 11137): Gamma, E-Beam, and X-Ray Complete Guide
A comprehensive guide to radiation sterilization under ISO 11137 — gamma irradiation, electron beam, and X-ray methods, dose establishment methods (VDmax, Method 1, Method 2), materials compatibility, the 2025 standard update, validation workflow, and quarterly dose audits.
Steam Sterilization (ISO 17665): Moist Heat Sterilization Complete Guide for Medical Devices
A comprehensive guide to ISO 17665 steam (moist heat) sterilization — process physics, the 2024 consolidated standard, IQ/OQ/PQ validation, F0 lethality calculations, biological indicators, overkill vs bioburden-based cycles, autoclave qualification, and routine monitoring.
QA vs QC in Medical Devices: Complete Comparison — Roles, Responsibilities, Organizational Structure & QMSR 2026 Impact
Quality Assurance vs. Quality Control in medical device manufacturing — proactive vs. reactive, process vs. product, responsibilities, tools, org structure, and how QMSR 2026 changes the landscape. Includes FDA 21 CFR 820 and ISO 13485 alignment.
3D Printed Medical Devices: FDA, EU MDR Regulatory Guide (2026)
Comprehensive guide to 3D printed medical device regulation — FDA pathways, EU MDR classification, patient-matched devices, point-of-care printing, process validation, biocompatibility, and key standards.
Brazil ANVISA Medical Device Cost Breakdown 2026: Exact Fees for Classes I-IV, BGMP Audit Schedule, MDSAP Carve-Outs, ANATEL/INMETRO Add-Ons
The definitive 2026 cost reference for ANVISA medical device registration — exact government fees by class in BRL and USD, BGMP audit costs and schedules, MDSAP carve-outs, ANATEL wireless fees, INMETRO electrical safety certification, and Brazilian Registration Holder retainer ranges.
KGMP Certification Guide for Foreign Manufacturers (2026): Complete Process, Requirements & Costs
Everything foreign manufacturers need to know about Korea Good Manufacturing Practice (KGMP) certification in 2026 — including MFDS requirements, application process, document checklist, audit types, costs, timeline, and how to prepare for the updated 2026 GMP regulations.