SAMD
When software has a medical purpose, it's a medical device. In Great Britain that means the UK Medical Devices Regulations 2002 (as amended), overseen by the MHRA, with UKCA marking (CE marking still recognised under transitional arrangements) - plus the DTAC standard if you're deploying into the NHS.
At Taylored Consultancy Ltd, we make software compliance clear and stress-free. From qualification and classification to your software lifecycle and clinical evidence, we help you meet UK requirements and keep pace with the MHRA's evolving software and AI framework.
Clearing the path to market -
regulatory and quality expertise that gets your software safe, compliant, and ready for market.
Is your software a medical device, and if so, what class? We assess intended purpose against UK rules and the IMDRF SaMD framework to confirm your regulatory status.
We help you put a compliant software development lifecycle in place, with the documentation auditors expect.
We help you compile clinical evidence demonstrating your software's safety and performance.
We build your risk management file, including software-specific and (where relevant) AI/ML risks.
We help you evidence usability and human-factors work to show your software is safe to use.
Deploying into the NHS? We help you meet the Digital Technology Assessment Criteria covering clinical safety, data protection, usability and interoperability.
For AI-enabled software, we help you address change management, bias and good machine learning practice - and explore routes like the MHRA AI Airlock.
Non-UK manufacturers need a UK Responsible Person and MHRA registration. We act as your RP and handle registration.
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
