AI Regulatory Strategy and QMS Integration
Is there an AI system, is it high-risk under Article 6(1), which obligations apply. Records the decision and maps Article 17 to your QMS. Includes AI literacy (Article 4).
EU AI Act · Medical Devices
EU AI Act Documentation for Medical Devices
Procedures and templates for AI-enabled medical devices under Regulation (EU) 2024/1689, as amended by Regulation (EU) 2026/1744. Three kits: an add-on to your ISO 13485 QMS, a complete QMS with the AI Act built in, or the full MDR device documentation with the AI Act inside.
- One QMS, one technical documentation
- Articles 9 to 17, 43, 72, 73 covered
- Annex IV mapped
- Word & Excel, fully editable
MD REGULATORY
AI Act
Medical Device Kit
Add-on to ISO 13485
- 8 procedures + 8 templates
- One procedure per process
- Plugs into your existing QMS
REGULATION (EU) 2024/1689
✦ For an existing QMS
Get the AI Act Kit →
EU AI Act Medical Device Kit
For manufacturers that already run an ISO 13485 quality system. Eight procedures add the AI Act where your QMS has gaps, as Article 17(3) allows: qualification, data governance, AI risk, development, conformity, changes, post-market monitoring and suppliers.
8 SOPs, one per process
AI qualification and classification record
QMS integration map (Article 17)
Dataset datasheet and AI model card
Annex IV index and DoC checklist
AI post-market monitoring plan
AI change assessment
AI supplier agreement clauses
€299
16 documents · Word, fully editable
MD REGULATORY
13485 + AI Act
Integrated QMS Kit
Complete quality system
- Quality manual + 31 SOPs
- 63 templates and logs
- AI Act inside the procedures
ISO 13485 · EU MDR · AI ACT
✦ Complete QMS
Get the Integrated Kit →
ISO 13485 + EU AI Act Documentation Kit
A complete ISO 13485 quality management system with the AI Act written into the procedures that produce the records: design control, risk management, change control, post-market surveillance, vigilance and supplier management. One QMS for the MDR and the AI Act.
QM-001 Quality Manual
31 SOPs, one per process
63 templates in Word and Excel
AI data governance procedure
AI model card and dataset datasheet
AI qualification record
6 operational logs
Master Index of 95 documents
€499SAVE €299
vs €798 buying the ISO 13485 kit and the AI Act kit separately
MD REGULATORY
MDR + AI Act
Device Documentation Kit
Technical file to PSUR
- 8 TD + 6 risk + 8 clinical/PMS
- 8 AI Act procedures
- Annex IV mapped into the TD
EU MDR · AI ACT · ISO 14971
✦ Premium Bundle
Get the MDR + AI Act Kit →
EU MDR + EU AI Act Documentation Kit
The device files a Notified Body reviews, with the AI Act built in: technical documentation, risk management, clinical evaluation, PMCF, PMS plan and PSUR, plus the AI Act procedures. One technical documentation and one declaration of conformity for both regulations.
8 technical documentation templates
Risk plan, hazard analysis, FMEAs, report
GSPR checklist (Excel)
CEP, CER, CDP, PMCF plan and report
SSCP, PMS plan and PSUR
8 AI Act procedures + 6 AI templates
Annex IV location map
Master Index of 36 documents
€999SAVE €299
vs €1,298 buying the MDR Complete Bundle and the AI Act kit separately
The eight AI Act processes
Every kit covers the same eight processes. In the AI Act kit and the MDR + AI Act kit each one is a procedure of its own; in the integrated kit it sits in the ISO 13485 procedure shown on the card.
AI Risk Management
Article 9 inside the ISO 14971 file: risks to health, safety and fundamental rights, data bias, automation bias, testing against predefined metrics, vulnerable groups.
AI Data Governance
Training, validation and test data: requirements, sourcing, labelling, bias examination, test-set independence, versioning. Article 10, with a datasheet per data set.
AI Design, Development and Validation
AI Act requirements as design inputs, performance per subgroup, robustness, human oversight and the information for users (Articles 13 to 15). Model card per version.
AI Technical Documentation and Conformity
One technical documentation with Annex IV, one declaration of conformity with Annex V, Notified Body route under Article 43(3), retention of records and logs.
AI Changes and Substantial Modifications
Retraining, new data, new model versions: when a change is a substantial modification (Article 3(23), 43(4)) and how it meets the MDR change rules.
AI Post-Market Monitoring and Incidents
Model performance in real use, input drift, user overrides, logs (Article 72), and the AI Act incident rules for medical devices (Article 73(10)).
AI Suppliers and Value Chain
Third-party AI components, data and general-purpose AI models: written agreements under Article 25(4) and the GPAI provider documentation (Article 53).