Medical Device & IVD Blog
Medical Device Quality Audits: The Complete Guide to FDA Inspections, ISO 13485, EU MDR, MDSAP & Internal Audits
The definitive guide to quality audits for medical devices — covering FDA QMSR inspections, ISO 13485 certification audits, EU MDR Notified Body audits, MDSAP, internal audits, supplier audits, audit findings classification, preparation timelines, and post-audit remediation.
Medical Device Industry News & Regulatory Updates: What Changed in 2026 and What's Coming Next
A comprehensive roundup of the most impactful medical device regulatory changes, FDA actions, EU MDR/IVDR milestones, and industry trends shaping 2026 — and what to prepare for in 2027.
Medical Device M&A & Funding: Due Diligence, Valuation, and the Investment Landscape in 2026
A comprehensive guide to medical device mergers & acquisitions, venture capital funding, and startup investment — covering regulatory due diligence, valuation methods, deal structures, and market trends.
Medical Device Process Validation: IQ, OQ, PQ, and the Complete Implementation Guide
A comprehensive guide to process validation for medical devices — covering IQ, OQ, PQ methodology, FDA and GHTF requirements, statistical tools, validation master plans, and continued process verification.
Medical Device Supply Chain Risk Management: The Complete Guide to Resilience, Compliance, and Supplier Quality
A comprehensive guide to medical device supply chain management — from supplier qualification and risk assessment to dual sourcing, quality agreements, and building supply chain resilience under FDA and ISO 13485.
Post-Market Clinical Follow-Up (PMCF) Under EU MDR: Plans, Studies, and the Complete Implementation Guide
A comprehensive guide to PMCF under EU MDR — covering PMCF plan development, study design, evaluation reports, integration with PMS and clinical evaluation, and practical implementation strategies.
Companion Diagnostics (CDx): Regulatory Pathways, Development, and Market Access
Complete guide to companion diagnostic device regulation — FDA CDx approval pathways, EU IVDR requirements, co-development with therapeutics, PMA/De Novo strategies, and real-world case studies from oncology to rare diseases.
Medical Device Labeling & UDI System: The Complete Regulatory Guide
Master FDA and EU MDR medical device labeling requirements, UDI system implementation, GUDID database submissions, and global UDI harmonization — practical guide with compliance checklists and common pitfalls.
Medical Device Policy & Legislation: Key Laws Shaping the Industry in 2026
Navigate the evolving medical device legislative landscape — from MDUFA V and the VALID Act to EU MDR implementation challenges, AI regulation, and global policy trends reshaping how devices reach patients.
Point-of-Care Testing (POCT): Regulatory Requirements, CLIA Waivers, and Market Trends
Comprehensive guide to point-of-care testing regulation — CLIA waiver requirements, FDA review pathways for POCT devices, EU IVDR classification, quality management, and the rapidly growing near-patient testing market.
Sustainability & ESG in Medical Devices: Regulatory Drivers, Circular Economy, and Industry Best Practices
How environmental sustainability, ESG reporting, and circular economy principles are transforming medical device design, manufacturing, and regulation — covering EU CSRD, FDA green initiatives, lifecycle assessment, and practical implementation strategies.
AI/ML in Medical Devices: FDA Regulatory Framework, SaMD Classification, and Approval Pathways
The complete guide to artificial intelligence and machine learning in medical devices — FDA's AI/ML action plan, predetermined change control plans, SaMD classification, 510(k) and De Novo pathways, EU MDR requirements, and Good Machine Learning Practice.
CAPA for Medical Devices: Corrective and Preventive Action Complete Guide
The definitive guide to CAPA in the medical device industry — FDA 21 CFR 820.198, ISO 13485 clause 8.5, root cause analysis methods, CAPA process steps, effectiveness checks, and common audit findings.
DHF, DMR, and DHR: Essential Medical Device Documentation Guide
Complete guide to the Device History File (DHF), Device Master Record (DMR), and Device History Record (DHR) — FDA requirements, ISO 13485 equivalents, contents, relationships, and practical implementation.
IEC 62366 Usability Engineering for Medical Devices: Complete Guide
The definitive guide to usability engineering for medical devices — IEC 62366-1:2015, FDA human factors guidance, usability engineering file, formative and summative evaluations, use-related risk analysis, and EU MDR usability requirements.
Supplier Quality Management for Medical Devices: Audits, Qualification, and Controls
The complete guide to supplier quality management in the medical device industry — FDA requirements, ISO 13485 clause 7.4, supplier qualification, audit programs, supplier agreements, risk-based controls, and MDSAP expectations.
510(k) Predicate Devices: How to Find, Evaluate, and Select the Right Predicate
Step-by-step guide to finding and selecting predicate devices for FDA 510(k) submissions — search strategies, substantial equivalence criteria, split predicates, and common selection mistakes.
CE Marking for Medical Devices: Requirements, Process, and Conformity Assessment Under EU MDR
The complete guide to CE marking medical devices under EU MDR — classification, conformity assessment routes, Notified Body selection, technical documentation, and step-by-step process.
Design Controls for Medical Devices: FDA Requirements, Process, and Implementation Guide
The complete guide to medical device design controls — FDA 21 CFR 820.30, ISO 13485 clause 7.3, the design control process, DHF requirements, traceability, and practical implementation.
FDA 510(k) Database: How to Search, Find Predicates, and Use Clearance Data
Step-by-step guide to searching the FDA 510(k) database — finding predicate devices, reading clearance summaries, using openFDA API, and leveraging 510(k) data for regulatory strategy.