IVD
IVD rules vary around the world, but most are built on the same risk-based foundations - the IMDRF/GHTF A to D model, robust performance evidence, and reliance on CE or FDA approvals to open new markets.
At Taylored Consultancy Ltd, we help you build a strong, internationally-minded evidence base - performance, risk and quality - then advise you closely on the specifics of each market so your diagnostics travel with the least friction.
Clearing the path to market -
regulatory and quality expertise that gets your diagnostics compliant, reliable, 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 IVD against the internationally harmonised risk-based A to D model adopted in varying forms worldwide.
We help you build a robust performance evidence base, aligned with CLSI guidelines, that can be adapted for multiple markets.
We build your risk management file to the recognised standard.
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 diagnostics.
We help you evidence usability and human-factors work to show your IVD is safe to use.
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.
ISO 13485 - Medical devices QMS
ISO 14971 - Risk management for medical devices
ISO 15189 - Medical laboratories quality and competence
ISO 15197 - Blood glucose monitoring systems
ISO 18113 - IVD labelling and instructions for use
ISO 23640 - Stability evaluation of IVD reagents
CLSI guidelines - Laboratory method validation
IEC 61326 - EMC requirements for laboratory equipment
ISO 9001 - General quality management
IEC 62366 - Usability Engineering
