Medical Device & IVD Blog
SaMD vs SiMD vs Embedded Software: Classification, Documentation, and Regulatory Strategy
Complete guide to distinguishing SaMD, SiMD, and embedded software for medical devices — IMDRF definitions, IEC 62304 classification, FDA and EU MDR regulatory pathways, MDCG 2019-11 guidance, documentation requirements, and practical decision frameworks for medtech manufacturers.
Sample Size Calculation for Medical Device Clinical Investigations: Practical Methods and Examples
Practical guide to sample size calculation and justification for medical device clinical investigations — ISO 14155:2026 requirements, EU MDR Annex XV expectations, FDA IDE statistical guidance, superiority vs non-inferiority vs equivalence designs, Bayesian approaches, adaptive sample size re-estimation, pilot study sizing, and worked examples for orthopedic, cardiovascular, and diagnostic accuracy studies.
Singapore Medical Device Registration Cost 2026: Singapore Registrant Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Singapore in 2026? A buyer-side breakdown of Singapore Registrant service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class A/B and Class C/D devices under HSA evaluation routes.
State of the Art Review for Medical Devices: SOTA Methods, Comparator Selection, and CER Examples
Complete guide to conducting a state of the art (SOTA) review for medical device clinical evaluation under EU MDR — regulatory definitions, SOTA methodology, comparator and benchmark device selection, clinical outcome parameters, MDCG 2020-6 evidence hierarchy, and practical examples for building a defensible CER.
Statistical Analysis Plan for Medical Device Trials: Endpoints, Estimands, Missing Data, and Sensitivity Analyses
Comprehensive guide to developing a Statistical Analysis Plan (SAP) for medical device clinical trials — ICH E9 and E9(R1) estimand framework, primary and secondary endpoint hierarchy, analysis populations (ITT, PP, safety), missing data strategies (MI, tipping-point), sensitivity and supplementary analyses, multiplicity adjustment, SAP timing and approval, and regulatory expectations from FDA, EMA, and EU MDR for device submissions.
Sunshine Act and Open Payments Reporting for MedTech Companies: Physician Payments Compliance Guide
Complete guide to Physician Payments Sunshine Act compliance for medical device manufacturers — covered recipients, reportable payment categories, 2026 thresholds, CMS submission process, state-level requirements, penalties, and audit preparation.
Switzerland Medical Device Registration Cost 2026: CH-REP Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does a Swiss Authorized Representative (CH-REP) cost in 2026? Pure Global publishes flat-fee CH-REP rates from $2,000/year for 1 device up to $4,000/year for 5 devices, all classes. Buyer-side breakdown of hourly billing vs registration-fee-plus-annual vs flat all-inclusive fee, with 3-year cash flow scenarios sized to the Swissmedic mandatory device registration deadline of July 1, 2026.
Thailand Medical Device Registration Cost 2026: Thai License Holder Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Thailand in 2026? A buyer-side breakdown of Thai License Holder service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class 1/2 listings/notifications and Class 3/4 notifications/licenses.
UK Medical Device Registration Cost 2026: UKRP Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in the UK in 2026? A buyer-side breakdown of UK Responsible Person (UKRP) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios that incorporate the new MHRA annual GMDN-category fee from April 2026.
USA Medical Device Registration Cost 2026: U.S. Agent Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
U.S. Agent and Official Correspondent fees run $1,000–$5,000+/year on top of FDA's $11,423 annual establishment fee. A buyer-side breakdown of hourly, registration-fee-plus-annual, and flat all-inclusive pricing models — with 3-year cash flow scenarios for foreign manufacturers selling into the United States in 2026.
User Needs vs Design Inputs for Medical Devices: How to Translate VOC into Verifiable Requirements
Complete guide to translating Voice of the Customer (VOC) and user needs into verifiable design inputs for medical devices — 21 CFR 820.30, FDA QMSR, ISO 13485, traceability matrix examples, and best practices for building audit-ready documentation.
Vietnam Medical Device Registration Cost 2026: Authorized Representative (AR/MAH) Pricing Models, Flat Fee vs Hourly, 3-Year Cash Flow
How much does it cost to register a medical device in Vietnam in 2026? A buyer-side breakdown of Vietnam Authorized Representative / Marketing Authorization Holder service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class A/B notifications and Class C/D registrations under Decree 98/2021 and Decree 07/2025.
EAEU Medical Device Registration Guide: Russia, Kazakhstan, Belarus, Armenia & Kyrgyzstan (2026–2028)
Complete guide to medical device registration in the Eurasian Economic Union (EAEU) — national vs EAEU pathway, risk classification (Class I–III), fees, timelines, authorized representative requirements, clinical evaluation, and the 2027/2028 transition deadlines for Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan.
GDPR Compliance for Medical Device and IVD Companies: A Practical Guide to EU Data Protection in 2026
Complete guide to GDPR compliance for medical device and IVD manufacturers — special category health data, Data Protection Impact Assessments, DPO requirements, lawful bases for processing, cross-border transfers, and how GDPR intersects with EU MDR, IVDR, and the AI Act.
Generative AI in Regulatory Operations for Medical Devices: Use Cases, Tools, and Compliance Guardrails in 2026
How medical device regulatory affairs teams are using generative AI in 2026 — drafting submissions, clinical evaluation, literature review, regulatory intelligence, and quality system compliance. Covers FDA guidance on AI in submissions, GxP requirements, governance frameworks, and practical implementation strategies.
Medical Device Go-to-Market Strategy: From FDA Clearance to Commercial Adoption
The complete go-to-market playbook for medical devices — regulatory-commercial alignment, hospital procurement, value analysis committees, sales channel models, pricing strategy, and the 18-month launch timeline from clearance to adoption.
Medical Device Product Liability and Insurance: A Complete Guide for Manufacturers
Everything medical device manufacturers need to know about product liability — strict liability vs negligence, insurance coverage types, EU Directive 2024/2853 changes, recall coverage, and risk mitigation strategies for 2026 and beyond.
SOUP (Software of Unknown Provenance): IEC 62304 Compliance Guide for Medical Device Manufacturers
The complete guide to managing Software of Unknown Provenance (SOUP) under IEC 62304 — identification, risk assessment, safety classification, documentation requirements, open-source management, and post-market surveillance strategies.
Environmental Compliance for Medical Devices: RoHS, REACH, WEEE, and Global Regulatory Guide
Complete guide to environmental regulations for medical devices — EU RoHS restricted substances and exemptions, REACH SVHC obligations and SCIP database, WEEE producer responsibilities, global RoHS adoption in China/Korea/Saudi Arabia, and manufacturer compliance strategies in 2026.
Internet of Medical Things (IoMT): Regulatory Compliance, Cybersecurity, and Market Access Guide
Complete guide to IoMT (Internet of Medical Things) regulatory requirements — FDA cybersecurity mandates for connected devices, SBOM requirements under Section 524B, EU MDR compliance for IoMT, market size, risk classification, and manufacturer obligations in 2026.