SAMD
Software medical devices are regulated differently across the world, but most frameworks share the same DNA - the IMDRF SaMD model, a quality-managed software lifecycle, and reliance on CE or FDA approvals to open doors elsewhere.
At Taylored Consultancy Ltd, we help you build a robust, internationally-minded foundation - your lifecycle, risk and clinical evidence - then advise you closely on each market you're targeting so your software travels with the least friction.
Clearing the path to market -
regulatory and quality expertise that gets your software safe, compliant, and ready for market - wherever you launch.
We help you plan a route to market across multiple countries, prioritising the approvals that unlock the most markets.
We assess your software against the internationally harmonised IMDRF SaMD framework adopted in varying forms worldwide.
We help you build a compliant, internationally-recognised software development lifecycle.
We build your risk management file (ISO 14971) and help you address AI-specific governance (ISO/IEC 42001, Good Machine Learning Practice).
We help you leverage CE or FDA approvals through the reliance routes many markets offer.
Almost every market requires a local representative. We help you understand and arrange the right one.
We help you implement a QMS to ISO 13485 - the universal baseline for software medical devices.
Every market has its own rules, and the detail matters. Get in touch for a free consultation and we'll map out exactly what your product needs, wherever you're headed.
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
