Manufacturing
63 articles
Refurbished Ultrasound Parts Purchasing Controls & Receiving Acceptance
A risk-based purchasing and receiving-acceptance workflow for used, tested, repaired, and refurbished ultrasound parts, informed by ISO 13485 Clause 7.4.
Ultrasound Board and Probe Repair Quality Agreement: Depot Deliverables and Clause Set
A contract-stage deliverables schedule and clause set for independent ultrasound repair depots, using 21 CFR 820.35(b) fields as a record template where appropriate.
Defense Production Act & Buy American for Medical Devices (2026)
A decision guide for medical device makers on U.S. domestic incentives: DPA Title III grants, Buy American Act thresholds, TAA exemptions, and tax rules.
SPC for Medical Devices: Cpk/Ppk Targets, Gauge R&R, and Process Validation
A quality engineering guide to statistical process control (SPC) and process capability (Cpk/Ppk) for medical device process validation, including Gauge R&R and FDA QMSR compliance.
ESU Recalls: ConMed, Stryker, Megadyne & Olympus Surgical-Fire and Burn Teardown
A manufacturer-spanning deep dive into FDA electrosurgical unit (ESU) recalls and MAUDE adverse event reports. Analyzes 640 recalls, surgical fire risks, and QMS implications.
Custom-Made Medical Devices Under EU MDR: Annex XIII and the FDA Exemption
A complete guide to custom-made medical devices under EU MDR Annex XIII. Learn about the manufacturer statement, MDCG 2021-3, and FDA CDE comparison.
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.