MedDeviceGuide — IVD & Medical Device Knowledge Base
Top Medical Device Consulting Firms: Choose a Regulatory & Quality Partner
Compare medical device consulting firms in 2026 across regulatory affairs, quality systems, clinical strategy, market access, pricing, and selection criteria.
Medical Device Clinical Trials: FDA IDE Requirements Guide
Understand FDA IDE requirements, 21 CFR 812 risk categories, study design, ISO 14155 alignment, submission steps, costs, and clinical trial timelines.
Medical Device Quality Audits: FDA, ISO 13485, EU MDR and MDSAP
Prepare for medical device quality audits, including FDA QMSR inspections, ISO 13485, EU MDR notified body audits, MDSAP, internal audits, findings, and remediation.
Medical Device Industry News and Regulatory Updates 2026
Roundup of 2026 medical device regulatory changes, FDA actions, EU MDR/IVDR milestones, and industry trends, plus what to prepare for in 2027.
Medical Device M&A and Funding: Due Diligence and Valuation Guide
Guide to medical device M&A, venture funding, startup investment, regulatory due diligence, valuation methods, deal structures, and 2026 market trends.
Medical Device Process Validation: IQ, OQ, PQ, and the Complete Implementation Guide
Implement medical device process validation with IQ, OQ, and PQ methods, FDA and GHTF expectations, statistical tools, master plans, and continued process verification.
Medical Device Supply Chain Risk Management and Supplier Quality
Manage medical device supply chain risk with supplier qualification, risk assessment, dual sourcing, quality agreements, FDA and ISO 13485 controls, and resilience planning.
EU MDR PMCF Guide: Plans, Studies, Reports, and Implementation
Guide to PMCF under EU MDR, including PMCF plans, study design, evaluation reports, PMS integration, clinical evaluation updates, and implementation.
Companion Diagnostics (CDx): Regulatory Pathways, Development, and Market Access
Guide to companion diagnostic regulation, including FDA approval pathways, EU IVDR requirements, therapeutic co-development, PMA and De Novo strategy, and market access evidence.
Medical Device Labeling & UDI System: The Complete Regulatory Guide
Understand FDA and EU MDR labeling requirements, UDI system setup, GUDID submissions, global UDI harmonization, compliance checklists, and common pitfalls.
Medical Device Policy & Legislation: Key Laws Shaping the Industry in 2026
Track medical device policy in 2026, from MDUFA V and VALID Act debates to EU MDR implementation, AI regulation, and global trends affecting market access.
Point-of-Care Testing (POCT): Regulatory Requirements, CLIA Waivers, and Market Trends
Guide to point-of-care testing regulation, including CLIA waivers, FDA pathways, EU IVDR classification, quality management, and near-patient market trends.
Sustainability & ESG in Medical Devices: Regulations and Best Practices
How sustainability, ESG reporting, and circular economy reshape medical device design, manufacturing, EU CSRD compliance, and lifecycle strategy.
AI/ML Medical Devices: FDA Framework, SaMD Classification, Approval Paths
Guide to AI and machine learning medical device regulation, covering FDA AI/ML policy, PCCPs, SaMD classification, 510(k), De Novo, EU MDR, and Good Machine Learning Practice.
CAPA for Medical Devices: Corrective and Preventive Action Complete Guide
CAPA guide for medical device quality systems, covering FDA QMSR, ISO 13485 clause 8.5, root cause analysis, CAPA steps, effectiveness checks, and common audit findings.
DHF, DMR, and DHR: Essential Medical Device Documentation Guide
Guide to DHF, DMR, and DHR documentation for medical devices, including FDA requirements, ISO 13485 equivalents, record contents, relationships, and practical implementation.
IEC 62366 Usability Engineering for Medical Devices: Complete Guide
Apply IEC 62366 usability engineering to medical devices, including the usability file, formative and summative evaluations, use-related risk analysis, FDA guidance, and EU MDR expectations.
Supplier Quality Management for Medical Devices: Audits, Qualification, and Controls
Medical device supplier quality guide covering FDA and ISO 13485 purchasing controls, qualification, audits, agreements, risk 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: EU MDR Requirements, Process, and Assessment
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.