FDA medical device consulting for manufacturers entering the US market. From device classification and predicate strategy to 510(k), De Novo and PMA submissions and the new QMSR, we guide you through the FDA pathway.
Market Essentials
The building blocks of FDA medical device compliance, from classification to post market obligations.
Scope
Class I, II or III and the right product code and regulation number. This single decision drives your whole submission strategy.
Pathway
The most common route. You demonstrate substantial equivalence to a legally marketed predicate device.
Pathway
For novel low to moderate risk devices with no suitable predicate. It creates a new classification you and others can then reference.
Pathway
The most demanding route, reserved for Class III devices and backed by clinical data from your own investigations.
Strategy
Early written feedback from the FDA on your test plan and regulatory route. Cheap to run and it prevents expensive detours.
Quality
From February 2026 the Quality System Regulation is aligned with ISO 13485. Your existing QMS still needs a gap assessment.
Registration
Annual registration of your facility and listing of every device you market in the United States.
Representation
Manufacturers outside the United States must name a US Agent as the FDA point of contact for communication and inspections.
Lifecycle
Unique Device Identification with GUDID submission, medical device reporting, complaint handling and recalls.
Stay up to date with FDA guidance, 510(k) practice, QMSR and digital health policy.
Our new website is live, and it’s more intuitive, easier to navigate and built around what medical device manufacturers need: information about the market you’re heading into and the stage your product has reached. Why we rebuilt it Our philosophy has always been a simple one. Getting a medical device to market is often more…
Join us for an intensive 1-day training on ISO 14971, the global standard for medical device risk management. This course is specifically designed for medical device manufacturers developing Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) and will cover how to integrate risk management throughout the software life cycle. What…
Medical device compliance is rarely the problem in theory. The challenge is making ISO 13485 and regulatory requirements work in real companies, with real products, limited time, and competing priorities. That’s exactly why we’ve launched Quality and Regulatory Compliance for Medical Device Manufacturers, a tailored, one-on-one training service designed to build practical, audit-ready capability inside your…