ISO 13485
58 articles
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.
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.
CSV to CSA Transition: FDA Computer Software Assurance Guide
How to move from CSV to FDA's Computer Software Assurance approach, covering risk-based validation, testing strategy, documentation, and a practical transition roadmap.
Engineering Change Order (ECO) for Medical Devices: Complete Process Guide
Medical device ECO guide covering ECR-to-ECN workflows, ISO 13485 design change controls, FDA QMSR expectations, risk assessment, regulatory triggers, and approvals.
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.
EU MDR PRRC Guide: Article 15 Responsibilities and 2026 Changes
Guide to the EU MDR Person Responsible for Regulatory Compliance, covering Article 15 qualifications, duties, outsourcing, MDCG guidance, liability, and 2026 changes.
FDA Inspection Readiness for Medical Devices: Complete Guide to QMSR Inspections in 2026
How to prepare for FDA medical device inspections under the new QMSR framework (CP 7382.850) — inspection types, the six QMS areas, common 483 observations, and a step-by-step readiness checklist.
FDA QMSR Inspection Preparation: Complete Guide to Compliance Program CP 7382.850
Prepare for FDA QMSR inspections under CP 7382.850 with the six QMS areas, OAFRs, risk-based methods, ISO 13485 alignment, and readiness steps.
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 13485 Implementation Guide: From Zero to Certification
Step-by-step guide to implementing ISO 13485 from scratch, covering QMS structure, clause requirements, documents, audit stages, costs, timelines, and FDA QMSR alignment.