MedDeviceGuide — IVD & Medical Device Knowledge Base
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.
Medical Device Third-Party Cybersecurity Risk Management Guide
Manage third-party cybersecurity risk for connected medical devices using FDA Section 524B, QMSR and ISO 13485 controls, SBOMs, vendor assessments, and threat modeling.
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.
Medical Device Trade Shows & Conferences 2026: The Complete Global Calendar
Plan 2026 medical device trade show attendance with dates, locations, and event focus for MEDICA, MD&M West, AdvaMed, RAPS, DeviceTalks, and other global conferences.
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.
Medical Device Interoperability: HL7, FHIR, and Connected Device Standards in 2026
Learn how HL7 FHIR, IEEE 11073, and DICOM support medical device interoperability, including CMS mandates, FDA expectations, and implementation guidance.
Privacy by Design for Medical Devices: Connected Healthcare Guide
Implement Privacy by Design in connected medical devices, with GDPR, HIPAA, data minimization, consent, anonymization, and 2026 privacy expectations.
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.
ASTM D4169 Transportation Validation for Medical Device Packaging
Guide to ASTM D4169 packaging validation, including distribution cycles, assurance levels, drop, compression and vibration tests, ISO 11607 links, sample size, and acceptance criteria.
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.
Colombia Medical Device Registration Cost 2026: INVIMA Rep Pricing Guide
Buyer-side guide to Colombia Representative pricing models, comparing hourly, annual, and flat-fee registration costs with 3-year cash flow examples.
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.
Costa Rica Medical Device Registration: Ministry of Health Guide
Guide to Costa Rica medical device registration through the Ministry of Health, covering classification, Spanish documents, legal and technical review, fees, timelines, and import permits.