ISO 13485 + EU AI Act
€499.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EN ISO 13485:2016/A11:2021 · EU MDR 2017/745 · REGULATION (EU) 2024/1689
ISO 13485 + EU AI Act Documentation Kit
A complete ISO 13485 quality management system with the EU AI Act requirements for AI-enabled medical devices written into its procedures.
An AI device needs one quality system, not two
A manufacturer of an AI-enabled device class IIa or above has to meet ISO 13485, the MDR quality system requirements of Article 10(9) and, for a high-risk AI system, Article 17 of the AI Act. Treated separately, that is three sets of procedures for the same design, the same risk file and the same post-market data.
Article 17(3) of the AI Act lets the AI requirements live inside the MDR quality system. The work is in the details: the design procedure has to cover training, validation and test data; risk management has to include Article 9; change control has to recognise a substantial modification; post-market surveillance has to monitor model performance; vigilance has to cover the AI Act incident rules.
None of these are hard problems. They are the consequence of adding the AI Act as an appendix instead of writing it into the procedures that already produce the records.
- 31 procedures
- 1 quality manual
- 63 templates
- Word and Excel
- One procedure per process
Scope
What the kit covers
The full set of ISO 13485 processes for a medical device manufacturer, organised in 31 packages: one procedure per process, with the templates that process produces. The AI Act requirements sit in the procedures where the work is done, and apply only to devices that your qualification record identifies as high-risk AI systems.
01
ISO 13485 and EU MDR
Quality manual, document control, management review, internal audit, CAPA, design control, risk management, clinical evaluation, vigilance, PMS, UDI, suppliers, production and labelling.
02
EU AI Act inside the QMS
AI qualification and classification, AI data governance, model card, Article 9 risk management, substantial modifications, AI post-market monitoring and Article 73 incidents.
03
Logs and evidence
Operational logs in Excel for CAPA, nonconformities, complaints, vigilance, changes and suppliers, with the KPIs each procedure defines.
Contents
31 packages: one procedure per process, with its templates
Audience
Who the kit is for
- Manufacturers building an ISO 13485 QMS for an AI-enabled device
- QA/RA managers rebuilding a QMS ahead of AI Act application
- PRRCs responsible for MDR and AI Act compliance
- Start-ups preparing for certification and the first Notified Body audit
- Consultants implementing a QMS for software and AI device clients
The kit assumes a working knowledge of ISO 13485 and the EU MDR. Devices without an AI function use the same procedures: the AI sections apply only where the qualification record identifies a high-risk AI system.
What is included
What you get when you buy
- 1 quality manual
- 31 standard operating procedures in Word
- 63 templates in Word and Excel, including 6 operational logs
- 3 AI templates: qualification record, model card, dataset datasheet
- A README with the order in which to implement the kit
- A Master Index cross-referencing all 95 documents
Questions
Before you buy
Do I need this kit if my device has no AI function?
It works as a complete ISO 13485 QMS for any device. The AI Act sections are written so that they apply only to devices qualified as high-risk AI systems. If you will never have AI in your portfolio, the ISO 13485 kit alone is enough.
Do I need to buy the ISO 13485 standard?
The procedures cite the clauses they implement, so you can work with the kit alone. Your certification body will expect you to have access to the standard, as with any QMS.
When do the AI Act requirements apply to medical devices?
From 2 August 2028 for high-risk AI systems covered by Annex I of the AI Act, which includes medical devices, after the amendment by Regulation (EU) 2026/1744.
Does it replace my current QMS?
It can, if you are building one. If you already have a certified QMS and only need the AI Act, the EU AI Act Medical Device Kit adds it to your existing procedures.
Does it cover the FDA QMSR and MDSAP?
The procedures cite FDA 21 CFR 820 (QMSR) and MDSAP where relevant, but the kit is built for ISO 13485 and the EU MDR. Country-specific submissions are not included.
Does it include the MDR technical documentation templates?
It includes the Medical Device File procedure and the technical documentation index. The full set of technical documentation, clinical and risk management templates is in the EU MDR + EU AI Act kit.
Do I need EN 18286 or ISO/IEC 42001?
No. The AI Act requirements are written into the procedures from the text of the regulation. EN 18286 is referenced where useful; ISO/IEC 42001 is not required.
What format are the files?
Procedures and most templates in Word; logs, the risk analysis matrix, the KPI dashboard and the master lists in Excel. Everything is editable, with placeholders for your company name.
Kit and course
The kit gives you the structure. The course explains the reasoning.
The course Artificial Intelligence in Medical Devices explains how the MDR and the AI Act apply to AI devices. The kit turns that into the procedures and records of your quality system.
ISO 13485 + EU AI Act Documentation Kit
Quality manual, 31 procedures and 63 templates in Word and Excel, with the EU AI Act built into the QMS.
€499.00
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