Medical Devices
Bringing a medical device to the US market means navigating the FDA, the Federal Food, Drug, and Cosmetic Act, and the right premarket pathway for your device.
At Taylored Consultancy Ltd, we cut through the confusion and provide clear, commercially focused regulatory support to help you launch with confidence. Whether you need help with a 510(k), establishment registration, or quality management systems, we make sure your device meets FDA requirements without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your medical devices FDA cleared, compliant, and trusted.
Unsure how your product is classified? We determine the correct FDA classification (Class I, II or III) and the controls that apply.
We conduct a full regulatory gap analysis against FDA requirements to identify any missing or incomplete documentation.
We help you determine and prepare the right submission - 510(k), De Novo, or PMA - so you follow the most efficient route to market.
We help compile and review your 510(k) submission, building the case for substantial equivalence to a suitable predicate device.
If your device comes into contact with the body, it needs biocompatibility testing. We help you identify the right testing requirements and ensure results are documented correctly.
We review your labelling and Unique Device Identifier (UDI) data to ensure all mandatory information is correct and listed in the GUDID database.
We handle FDA establishment registration and device listing, ensuring your product is correctly listed before it enters the market.
Foreign manufacturers must designate a US Agent. We help you put the right arrangement in place so your device stays compliant.
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.
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
FCC - Federal Communications Commission requirements for Bluetooth / Wi-Fi
21 CFR 820 / QMSR - FDA Quality Management System Regulation
Get our instant-download US Medical Device Regulations cheat sheet: classification, route to market and labelling essentials in one clear guide, for £15.
