MedDeviceGuide — IVD & Medical Device Knowledge Base
ISO/TR 24971 for Medical Devices: Practical Guidance for Applying ISO 14971
Comprehensive guide to ISO/TR 24971:2020, the companion technical report to ISO 14971:2019 — how to use its annexes for hazard identification, risk analysis methods, benefit-risk analysis, cybersecurity, IVDs, and practical implementation across your risk management process.
Literature Search Protocol for EU MDR Clinical Evaluation: Databases, Appraisal, and CER Evidence
Step-by-step guide to creating a compliant literature search protocol for medical device clinical evaluation under EU MDR Article 61 and Annex XIV — MEDDEV 2.7/1 Rev. 4 methodology, PICO framework, database selection, inclusion/exclusion criteria, critical appraisal, PRISMA documentation, and Notified Body expectations.
Malaysia Medical Device Registration Cost 2026: MAR Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Malaysia in 2026? A buyer-side breakdown of Malaysia Authorized Representative (MAR) 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, plus the CAB-MDA-MAR three-fee structure decoded.
Medical Device Distribution Agreements: Regulatory Clauses, Importer Duties, and Territory Control
Complete guide to medical device distribution agreements — regulatory clauses, EU MDR Article 14 importer obligations, FDA initial distributor requirements, exclusivity and territory provisions, PMS and vigilance obligations, quality agreements, and negotiation strategies for medtech manufacturers.
Medicare NCD vs LCD for Medical Devices: Coverage Determination Strategy and Evidence Requirements
Complete guide to Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) for medical device manufacturers — how each process works, evidence requirements, timelines, the new RAPID pathway, Coverage with Evidence Development, MAC jurisdictions, and practical strategies for securing Medicare coverage.
Mexico Medical Device Registration Cost 2026: MRH Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
Pure Global publishes Mexico MRH service at $2,000/year flat for Class I and $3,000/year for Class II/III — versus $15,000–$30,000 Year 1 under hourly billing. A buyer-side breakdown of Mexico Registration Holder (MRH) pricing models with 3-year cash flow scenarios, switching playbook, and RFP template for COFEPRIS submissions and the Equivalence Pathway.
New Zealand Medsafe Medical Device Registration Guide: WAND, Sponsor Duties, and Reliance Pathways
Complete guide to registering medical devices in New Zealand — Medsafe WAND database notification process, sponsor requirements, GHTF classification, adverse event reporting, labeling obligations, TTMRA mutual recognition with Australia, and practical timeline and cost estimates for market entry.
NTAP Application Guide for Medical Devices: New Technology Add-On Payment Criteria, Timeline, and Strategy
Complete guide to CMS New Technology Add-On Payment (NTAP) for medical device manufacturers — eligibility criteria (newness, cost, substantial clinical improvement), traditional vs alternative pathways, FY 2027 application timeline, MEARIS submission, Town Hall process, payment calculation, and proposed changes to Breakthrough Device fast-track pathways.
Pakistan DRAP Medical Device Registration Guide: Classification, Import Licensing, and Local Agent Requirements
Complete guide to registering medical devices in Pakistan — DRAP Medical Devices Rules 2017, four-tier A/B/C/D classification system, establishment licensing, online e-service portal launched July 2025, authorized representative requirements, dossier preparation, registration fees, labeling in English and Urdu, adverse event reporting, post-market surveillance, and practical timeline and cost estimates.
Patient-Reported Outcomes in Medical Device Trials: PRO Instruments, Validation, and FDA/EU Expectations
Guide to selecting, validating, and using patient-reported outcome (PRO) instruments in medical device clinical trials — FDA CDRH draft guidance on fit-for-purpose PROs, EU MDR clinical evaluation requirements, COA types (PRO, ClinRO, ObsRO, PerfO), instrument validation, endpoint hierarchy, and regulatory submission strategies.
Risk Management File vs Risk Management Report: ISO 14971 Documentation Explained
Clear guide to the differences between a risk management file and risk management report under ISO 14971:2019 — what each contains, how they relate, traceability requirements, and common audit findings from notified bodies and FDA.
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.