Coming Soon: The AI Traceability Journal by Hoodin
- Team Hoodin
- Jun 16
- 1 min read
System-level execution for MDR, IVDR, and ISO 13485 §4.1.3
You’re likely knee-deep in technical documentation updates, legacy device assessments, or notified body prep. The expectations under Article 10.9, Annex II Section 4, and ISO 13485 §4.1.3 are no longer theoretical — they’re operational.
That’s why we’re launching The AI Traceability Journal — a monthly brief to help you execute on the system-level demands of MDR, IVDR, and cross-domain regulations.
Each edition (June 2025 to December 2026) delivers practical, hands-on guidance aligned with what regulatory professionals are doing — and struggling with — right now: – Building traceable technical files – Managing regulatory updates at scale – Justifying decisions under scrutiny – Creating audit-ready documentation across multiple markets
This series is written for RA/QA professionals, PRRCs, consultants, and compliance managers who need to not only understand the law, but build it into daily operations.
First edition drops already on Thursday, June 19th!