リソーステンプレート

テンプレート

専門家が設計したテンプレートとチェックリストでコンプライアンスを加速してください。

Marketing Asset Templates for MedTech Launch

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.

Post-Market

PMS Plan Template: Risk-Based Monitoring for Class II/III Devices

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.

Market Access

MedTech Brand Launch Playbook for Startups

A 90-day operational playbook covering brand identity, sales enablement, channel readiness, and first-customer execution — built for first-product MedTech startups.

Cybersecurity

SBOM Best Practices for FDA Cybersecurity Submissions

A working SBOM template in SPDX and CycloneDX formats with FDA-aligned metadata fields, vulnerability mapping, and example entries for medical device software.

Design & Development

Design Inputs to Design Outputs: A Discovery Phase Checklist

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.

Quality & QMS

KGMP Audit Readiness: 8-Week Sprint Plan and Document Checklist

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.