Medical Devices
Every market has its own rules for medical devices, but most are built on the same international foundations - risk-based classification, a quality management system, and a local representative to hold your registration.
At Taylored Consultancy Ltd, we help you build a single, robust regulatory and quality foundation that travels. We make the most of international harmonisation (IMDRF) and reliance routes so your CE or FDA approvals can open doors in other markets - then we advise you closely on the specifics of each country you're targeting.
Clearing the path to market -
regulatory and quality expertise that gets your medical devices market-ready, compliant, and trusted - wherever you launch.
We help you plan a route to market across multiple countries, prioritising the approvals and evidence that unlock the most markets.
Many markets accept CE marking or FDA clearance through reliance routes. We help you leverage existing approvals to enter new regions faster.
We determine how your device is likely to be classified across target markets using internationally harmonised (IMDRF) principles.
We build technical documentation to international standards so it can be adapted efficiently for each market, rather than rebuilt from scratch.
We help develop and implement a QMS to ISO 13485 - the universal baseline accepted around the world - and ISO 9001.
Almost every market requires an in-country representative or licence holder. We help you understand and arrange the right local representation for each region.
Wherever you're heading, we identify what's missing and support you through audits and inspections.
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
ISO 9001 - General
ISO 14971 - Risk management for medical devices
ISO 10993 - Biocompatibility
IEC 60601 - Electrical safety and electromagnetic compatibility for medical devices
ISO 11135 - Ethylene oxide sterilisation of medical devices
ISO 11607 - Packaging for terminally sterilised medical devices
ISO 15378 - Primary packaging materials for medicinal products
ISO 14155 - Clinical investigation conduct
EN 62304 - Software within a medical device
IEC 61326 - EMC requirements for electrical equipment
ISO 15197 - Blood glucose monitoring systems
2014/53/EU - Radio Equipment Directive (Bluetooth / Wi-Fi)
FCC - Federal Communications Commission requirements for Bluetooth / Wi-Fi
MDSAP - Medical Device Single Audit Programme
IMDRF guidance - International harmonisation
