Regulatory
567 articles
Robotic Surgery Devices: FDA and EU MDR Regulatory Pathway Guide
Regulatory strategy guide for surgical robots, covering FDA pathways, EU MDR expectations, autonomy levels, software controls, human factors, and clinical evidence.
RUO vs IUO vs IVD Labeling: Research, Investigational, and Diagnostic Boundaries
Practical guide to RUO, IUO, and IVD labeling boundaries, covering intended use, FDA guidance, diagnostic-use triggers, marketing risk, and classification decisions.
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.
Washer-Disinfector Validation: ISO 15883, A0 and Routine Monitoring
Validate washer-disinfector equipment and cycles under ISO 15883, including IQ/OQ/PQ, A0 thermal disinfection, load configurations and routine monitoring.
EU MDR Well-Established Technologies: Expanded WET Device List 2026
Guide to the 2026 EU MDR Well-Established Technology delegated acts, expanded device lists, clinical investigation exemptions, conformity assessment changes, and manufacturer steps.
Health Canada Medical Device Regulation Reform 2026
Understand Health Canada's 2026 device reforms, including Terms and Conditions powers, AI/ML guidance, REP, IMDRF ToC, significant changes, and market access actions.
Medical Device Penetration Testing and Vulnerability Assessment
See how penetration testing, vulnerability scanning, and fuzz testing support FDA and EU MDR cybersecurity evidence for connected medical device submissions.
CMS-FDA RAPID Coverage Pathway: Fast-Track Medicare Coverage for Breakthrough Devices
Explains the 2026 CMS-FDA RAPID pathway for Breakthrough Devices, including Medicare coverage timing, eligibility, IDE study planning, and manufacturer preparation.
FDA Cybersecurity Guidance QMSR Update 2026: What Must Change
Guide to FDA's February 2026 premarket cybersecurity guidance update for QMSR and ISO 13485 alignment, including what changed, what stayed, mapping, and connected device steps.
FDA General Wellness Policy for Wearables: 2026 Non-Device Guide
Guide to FDA's 2026 General Wellness policy for wearable devices, including non-regulated wellness criteria, physiologic parameter examples, claim boundaries, and compliance steps.
Medical Device Recall Trends 2024-2026: Statistics and Root Causes
Analyze 2024-2026 medical device recall trends, including Class I increases, device failure causes, software defects, FDA alerts, affected units, and risk mitigation.
RAC Certification Guide 2026: RAPS Exam Prep for Regulatory Affairs
Prepare for the 2026 RAPS RAC exam with guidance on RAC-Devices vs RAC-Drugs, eligibility, exam content, testing windows, study resources, and career impact.
AR/VR Medical Devices: FDA Pathways, Classification, and 2026 Guide
Guide to AR and VR medical device regulation in 2026, including FDA classification, product codes, 510(k) and De Novo routes, cleared devices, surgical navigation, therapeutic VR, and human factors.
Regulatory Affairs Career Guide for Medical Devices: Paths, Salaries, Skills
Career guide for medical device regulatory affairs, covering role progression, salary ranges, RAC certification, core skills, and entry strategies for 2026.
ISO 17025 Test Laboratory Selection for Medical Devices: Complete Guide
Guide to selecting ISO 17025 accredited laboratories for medical device biocompatibility, EMC, safety, and sterilization testing, including FDA ASCA scope checks and cost factors.
Australia Medical Device Registration Cost: Sponsor Pricing Guide (2026)
Buyer-side guide to Australia medical device registration costs, sponsor pricing models, flat fees versus hourly billing, and 3-year cash flow for ARTG inclusion across device classes.
Bangladesh DGDA Medical Device Registration Guide
Guide to Bangladesh DGDA device registration, covering Class A-D classification, Recipe Approval, registration, representative duties, import licensing, Bengali labeling, fees, and timelines.
Benefit-Risk Analysis for Medical Devices: FDA, EU MDR, and ISO 14971 Decision Framework
Guide to medical device benefit-risk analysis, covering ISO 14971 residual risk, EU MDR AFAP expectations, FDA benefit-risk factors for PMA, De Novo, and 510(k), examples, and documentation.
Brazil Medical Device Registration Cost: BRH Pricing Guide (2026)
Buyer-side guide to Brazil medical device registration costs, BRH pricing models, hourly versus flat fees, and 3-year cash flow for Class I/II notifications and Class III/IV registrations.
Clinical Equivalence Under EU MDR: Technical, Biological, and Clinical Criteria
Demonstrate clinical equivalence under EU MDR Article 61 and Annex XIV, including MDCG 2020-5 criteria, data access, gap analysis, and CE marking examples.