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
Most Class II devices need a 510(k) premarket notification, which shows the FDA your device is substantially equivalent to a legally marketed predicate device already on the US market, but not every device needs one. Many Class I devices are exempt, while higher-risk or genuinely novel devices may instead need a De Novo request or full Premarket Approval (PMA), so the right pathway depends on your device's classification and whether a suitable predicate exists.
A 510(k) shows your device is substantially equivalent to an existing predicate device and covers most Class II devices; De Novo is for novel low-to-moderate risk devices with no predicate to compare against; and PMA is the most rigorous route, reserved for high-risk Class III devices, requiring clinical data proving safety and effectiveness. Picking the wrong pathway early on is one of the most common and costly mistakes we see manufacturers make.
Yes, the FDA requires every foreign manufacturer to appoint a US Agent, a US-based point of contact who assists with FDA communications, including facilitating inspection scheduling and receiving official correspondence on your behalf. It's a legal requirement for registration, not an optional extra, and the US Agent doesn't take on regulatory responsibility for your device, which stays with you as the manufacturer.
QMSR is the FDA's updated Quality Management System Regulation, replacing the older 21 CFR 820 Quality System Regulation by incorporating ISO 13485 directly by reference rather than running a similar-but-separate US-specific standard alongside it. In practice this brings the US much closer in line with the rest of the world, so manufacturers already certified to ISO 13485 for other markets have a real head start on US compliance.
FDA classification runs from Class I (lowest risk, generally exempt from premarket submission) through Class II (moderate risk, typically needing a 510(k)) to Class III (highest risk, usually requiring full PMA), based on the level of control needed to reasonably assure safety and effectiveness. Getting the classification right early shapes everything downstream, from testing requirements to which premarket pathway is even available to you.
Yes. Before marketing a device in the US, manufacturers (or their US Agent, for foreign manufacturers) need to complete FDA establishment registration and list the device, which includes entering it into the GUDID database with its Unique Device Identifier. This has to be renewed annually and kept current whenever your device or company details change, so it's ongoing admin rather than a one-off task.
Still have questions? Contact us and we'll be happy to help.
