This session provides a conceptual walkthrough of how specialised RA/QA agents support interpretation, rationale documentation, and continuous update awareness — without automating decisions or replacing professional judgement.
Key Topics Covered
The problem: regulatory work no longer fits its old model
Compliance is no longer episodic
Under MDR, IVDR, and ISO 13485, regulatory work must function continuously. Applicable requirements are expected to be identified, justified, and maintained throughout the product lifecycle — not reconstructed in preparation for an audit.
Manual approaches break under regulatory complexity
Diverging market requirements, frequent regulatory updates, and increasing documentation demands make manual compliance work unsustainable. The result is higher workload, increased risk, and inconsistent applicability decisions across products and markets.
The solution: a structured system for continuous compliance
Applicable Lists as a controlled, living system
Hoodin Compliance Studio structures Applicable Lists around product scope, regulatory frameworks, applicability decisions, and documented rationales — creating built-in traceability and audit readiness by design.
Continuous regulatory change control, supported by AI
The platform continuously monitors regulatory changes and provides structured insights and decision support to RA/QA teams, helping them assess impact and act in a controlled way. All applicability decisions and justifications remain fully owned, reviewed, and approved by the regulatory function.