Manufacturing
57 articles
Acceptance Sampling Plans for Medical Devices: AQL, Z1.4 & ISO 2859
How to build statistically valid medical device sampling plans under 21 CFR 820.250 / ISO 13485: AQL, ANSI/ASQ Z1.4, ISO 2859-1 switching rules, c=0 plans, and OC curves.
Medical Device Reliability Testing: HALT, HASS, ALT & MTBF
A practical guide to medical device reliability testing: HALT vs HASS vs accelerated life testing, Weibull and MTBF, Arrhenius acceleration, and where it fits in ISO 13485 design V&V.
FDA Establishment Registration Lookup: Manufacturer, Importer, and US Agent Roles
How to read an FDA establishment registration to identify manufacturer, contract manufacturer, importer, and US agent roles — with role-count data.
eDHR for Medical Devices: QMSR, Part 11 & Digital Manufacturing (2026)
eDHR implementation guide for medical device manufacturers: QMSR requirements, 21 CFR Part 11, MES integration, ISO 13485, paper-to-digital migration, and inspection readiness.
Medical Device Reshoring and Nearshoring Strategy Guide (2026)
Evaluate medical device reshoring and nearshoring decisions in 2026, including tariffs, QMSR and ISO 13485 implications, cost trade-offs, supply risk, and IP protection.
Iran War Impact on Medical Device Supply Chains and Strait of Hormuz Risk
Analysis of how Iran conflict and Strait of Hormuz disruption could affect medical device supply chains, including helium, plastics, freight, insurance, and sourcing strategy.
Adhesive Bonding Process Validation for Medical Devices: From Variables to IQ/OQ/PQ
How to validate adhesive bonding for medical devices, including ISO 13485 and FDA QMSR requirements, UV and epoxy variables, IQ/OQ/PQ protocols, surface controls, and revalidation triggers.
Antibody Clone Lock and Lot-to-Lot Bridging for Immunoassay IVD Kits
How to lock antibody clones, manage lot-to-lot bridging studies, and maintain immunoassay IVD performance across manufacturing campaigns under FDA QMSR, ISO 13485, and EU IVDR.
Battery Cell Sourcing for Portable Medical Devices: Supplier Qualification
How to qualify battery suppliers and design medical device battery packs, covering chemistry selection, IEC 62133-2, UN 38.3, BMS controls, traceability, quality agreements, and dual sourcing.
Biological Specimen Sourcing for IVD Development: Serum, Plasma, Matrix
How to source serum, plasma, urine, CSF, and matrix materials for IVD calibrators and controls, covering donor qualification, viral testing, traceability, lot consistency, and regulatory expectations.
Calibrators and Controls Traceability for IVD Kits
How to establish traceability for IVD calibrators and controls, covering ISO 17511 hierarchy models, reference materials, commutability, uncertainty, value assignment, and regulatory expectations.
CDMO Quality Agreement RACI for Sub-Tier Supplier Control
How to structure RACI matrices in CDMO quality agreements for sub-tier supplier control, defining OEM, CDMO, and supplier accountability under ISO 13485, FDA QMSR, and EU MDR.
Coatings and Surface Treatment Supplier Controls for Medical Devices
How to qualify coating and surface treatment suppliers, covering audits, IQ/OQ/PQ validation, specifications, biocompatibility, quality agreements, and monitoring.
Contract Cleanroom Assembly Qualification for Medical Devices
How to qualify contract cleanroom assembly vendors, covering cleanroom classification, environmental monitoring, gowning qualification, quality agreements, audits, and ongoing controls.
Contract Packaging Vendor Qualification for Medical Devices
How to qualify contract packaging vendors, covering ISO 11607 capability, sterile barrier systems, seal validation, labeling, sterilization coordination, quality agreements, and oversight.
Depot Repair QMS for Reusable Medical Device Capital Equipment
How to build a depot repair QMS for reusable capital equipment, covering intake, decontamination, testing, rework, calibration, nonconformance, release, and ISO 13485 records.
Enzyme Supplier Qualification for PCR and RT-qPCR IVD Kits
Guide to qualifying PCR and RT-qPCR enzyme suppliers for IVD kits, covering Taq polymerase, reverse transcriptase, lot bridging, acceptance specs, stability, change control, and FDA/IVDR expectations.
IVD CDMO Tech Transfer Readiness Package: Complete Guide for Diagnostic Manufacturers
Prepare an IVD CDMO tech transfer readiness package with manufacturing specs, analytical method transfer, quality agreements, validation roles, and FDA, ISO 13485, and IVDR expectations.
Legacy Medical Device Transfer to a CDMO: DMR, Validation, and Regulatory Strategy
How to transfer legacy medical device manufacturing to a CDMO while managing DMR handoff, tacit knowledge, change control, process revalidation, and regulatory continuity.
Lyophilized Reagent Fill-Finish and Stability Strategy for IVD Kits
Guide to lyophilized reagent fill-finish for IVD kits, covering formulation, bead and cake formats, humidity control, residual moisture, stability studies, and regulatory documentation.