SAMD
When software has a medical purpose, it's a medical device under the EU Medical Device Regulation (EU 2017/745). Qualification and classification follow MDCG 2019-11 and Rule 11 - which places most clinical software in Class IIa or above - and the EU AI Act now layers additional obligations onto AI-enabled devices.
At Taylored Consultancy Ltd, we make software compliance clear and stress-free. From qualification and classification to your technical documentation and AI Act readiness, we help you CE mark and meet EU requirements without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your software safe, compliant, and ready for market.
We assess your software against MDCG 2019-11 and Rule 11 to confirm whether it's a medical device and which class applies.
We help you put a compliant software development lifecycle in place, with the documentation a Notified Body expects.
We help you compile clinical evidence and a Clinical Evaluation Report to support CE marking.
We build your risk management file, including software and AI/ML-specific risks.
We help you evidence usability and human-factors work for safe use.
For AI-enabled devices, we help you understand and prepare for the AI Act obligations that sit alongside EU MDR.
Non-EU manufacturers need an EU Authorised Representative and EUDAMED registration. We act as your EC REP and handle registration.
We help you prepare for and respond to Notified Body assessment of your technical documentation and QMS.
We help you implement a QMS to ISO 13485, the backbone of software medical device compliance.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
EN 62304 / IEC 62304 - Medical device software lifecycle
IEC 82304-1 - Health software products
IEC 62366-1 - Usability / human factors engineering
ISO 14971 - Risk management for medical devices
ISO 13485 - Medical devices QMS
ISO/IEC 42001 - AI management systems
ISO 9001 - General quality management
