Accelerate your compliance journey with our expert-designed templates and checklists.
A ready-to-use pack of regulatory-aligned marketing asset templates — brochures, detail aids, web pages, and pitch decks — pre-structured for FDA, EU, and Korean MFDS review.
A structured PMS Plan template aligned with ISO 13485, EU MDR Article 84, FDA 21 CFR 820.100, and MFDS Article 31 — with data source matrices and analysis cadence templates.
A 90-day operational playbook covering brand identity, sales enablement, channel readiness, and first-customer execution — built for first-product MedTech startups.
A working SBOM template in SPDX and CycloneDX formats with FDA-aligned metadata fields, vulnerability mapping, and example entries for medical device software.
A complete checklist for the design controls discovery phase — user needs, design inputs, intended use, risk, regulatory strategy — before a line of code is written or a CAD file created.
A week-by-week preparation plan for foreign manufacturers facing a first-time or surveillance KGMP audit, with a complete document checklist and an internal mock-audit script.
Test post used to validate the OTP email + verified-download flow on the template detail page.
