Commercialization

Guide to MDUFA VI for 2027-2032, covering FDA device user fee changes, CDRH staffing, real-world evidence provisions, fee projections, and preparation steps.

How FDA and CDRH staffing reductions may affect 510(k) reviews, pre-submission meetings, MDUFA goals, and regulatory planning for device companies.

Guide to the GLP-1 drug delivery device ecosystem, including auto-injector pens, oral delivery, combination product pathways, FDA, EU MDR, and market outlook.

Independent comparison of regulatory intelligence software for medical device and IVD teams, covering RegDesk, IQVIA, Cortellis, Obsidian, Basil Systems, ArisGlobal, Freyr, and Veeva.

Explains the 2026 CMS-FDA RAPID pathway for Breakthrough Devices, including Medicare coverage timing, eligibility, IDE study planning, and manufacturer preparation.

Guide to FDA's 2026 General Wellness policy for wearable devices, including non-regulated wellness criteria, physiologic parameter examples, claim boundaries, and compliance steps.

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.

Career guide for medical device regulatory affairs, covering role progression, salary ranges, RAC certification, core skills, and entry strategies for 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.

Guide to Bangladesh DGDA device registration, covering Class A-D classification, Recipe Approval, registration, representative duties, import licensing, Bengali labeling, fees, and timelines.

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.

Buyer-side guide to Colombia Representative pricing models, comparing hourly, annual, and flat-fee registration costs with 3-year cash flow examples.

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.

Guide to CPT, HCPCS, and ICD coding strategy for medical device reimbursement, including when to seek new codes, AMA and CMS processes, payment systems, and market access planning.

Buyer-side breakdown of EU medical device registration costs in 2026, comparing EC REP hourly, registration-plus-annual, and flat-fee pricing with three-year scenarios.

Compare Hong Kong MDACS registration and LRP pricing models, including flat fees, hourly billing, 3-year cash flow, government fee status, and transition planning.

Register medical devices in Hong Kong through MDACS, including LRP duties, classification, reference pathways, Stage C procurement rules, fees, timelines, and transition planning.

Compare Indonesia LAR pricing models for medical device registration, including hourly, annual, and flat-fee structures, AKD/AKL cash flow, and importation fee mechanics.

Buyer-side guide to Malaysia medical device registration costs, comparing MAR hourly, annual, and flat-fee pricing models with 3-year cash flow scenarios and CAB-MDA-MAR fee structure.

Draft distribution agreements with EU MDR importer duties, FDA distributor controls, territory and exclusivity terms, PMS, vigilance, quality, and negotiation clauses.