ISO 13485
47 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.
GAMP 5 Computerized System Validation for Medical Devices (2nd Ed.)
A practical guide to GAMP 5 Second Edition for medical device manufacturers: software categories, the V-model, critical thinking, FDA CSA alignment, data integrity, and 21 CFR Part 11.
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 QMSR Remediation Mandate: Pre-2026 Findings Now Require ISO 13485
IsoTis and Longhorn warning letters set FDA precedent: pre-QMSR corrective actions must now meet ISO 13485. Internal audit exposure, risk citations, and prep steps.
ISO 19011:2026: What the Updated Audit Standard Means for Medical Device Manufacturers
ISO 19011:2026 embeds hybrid auditing, digital evidence management, and updated auditor competence across the audit lifecycle — what ISO 13485 and QMSR programs need to update.
ISO 13485 Audit Findings: Most Common Nonconformities by Clause and How to Prevent Them
The ISO 13485 clauses most cited in audit findings — root causes and corrective actions for document control, CAPA, design controls, suppliers, internal audits, and process validation.
Medical Device Design Verification Test Protocol Guide
Write and execute verification test protocols with clear scope, acceptance criteria, sample size rationale, results, and FDA, EU MDR, and ISO 13485 alignment.
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.
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.
Process Validation Ownership at a CMO/CDMO: Who Writes, Who Runs, Who Approves
Assign process validation ownership between OEMs and CMOs/CDMOs, covering protocol authorship, IQ/OQ/PQ execution, approvals, and ISO 13485, FDA QMSR, and GHTF accountability.
QMSR Supplier Quality Agreements for Cloud, AI, Cybersecurity, and Test Vendors
Draft QMSR supplier quality agreements for cloud, AI, cybersecurity, testing, and sterilization vendors with audit, CAPA, change notice, and evidence clauses.
Medical Device CDMO Market 2026: Growth, Key Players, and Outsourcing
Analysis of the 2026 medical device CDMO market, including growth forecasts, major players, M&A trends, outsourcing drivers, and partner selection criteria.
Supplier Audit Checklist for Medical Devices: ISO 13485, QMSR, and Critical Suppliers
Use this supplier audit checklist for ISO 13485 and FDA QMSR compliance, covering supplier risk, qualification, audit agendas, quality agreements, CAPA follow-up, and records.
Agile vs Waterfall for Medical Device Software: IEC 62304 Audit Evidence
How to choose Agile, Waterfall, or hybrid medical device software development under IEC 62304, with AAMI TIR45 mapping, design controls, and auditor evidence expectations.
Medical Device CMO Selection and Quality Agreement Guide
How to select a medical device CMO, define quality agreements, run supplier audits, manage change control, and align outsourced manufacturing with FDA QMSR and ISO 13485.
Design Output Documentation for Medical Devices: Drawings, Specs, BOMs
Guide to medical device design output records, including drawings, specifications, BOMs, acceptance criteria, and traceability to design inputs under FDA QMSR and ISO 13485.
Design Review Evidence for Medical Devices: Agenda, Minutes, Independence
Guide to medical device design review records, covering agenda planning, meeting minutes, independent reviewers, FDA and ISO expectations, and audit-ready evidence.
Design Transfer to Manufacturing: DMR, Validation, and Supplier Handoff
Guide to medical device design transfer, including DMR readiness, IQ/OQ/PQ process validation, supplier qualification, production handoff, and audit-ready documentation.
Batch Records for Medical Devices: BMR, EBR, DHR, and FDA QMSR
Guide to batch manufacturing records, electronic batch records, and DHRs for medical devices, covering 21 CFR 210/211, FDA QMSR, ISO 13485, review workflows, deviations, and inspection readiness.