SAMD
In the US, software with a medical purpose is regulated by the FDA as a medical device, typically via the 510(k) or De Novo pathway. The FDA has built a clear approach to digital health and AI/ML, including Predetermined Change Control Plans (PCCPs) that let you pre-authorise certain software changes.
At Taylored Consultancy Ltd, we make software compliance clear and stress-free. From the right premarket pathway to your software lifecycle and AI change-control plan, we help you meet FDA requirements without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your software safe, compliant, and ready for market.
We help you determine the right route - 510(k), De Novo, or PMA - and prepare your submission.
We assess whether your software is a regulated device function and how the FDA is likely to treat it.
We help you put a compliant software development lifecycle and documentation in place.
We build your risk management file, including software and AI/ML-specific risks.
For AI-enabled software, we help you prepare a Predetermined Change Control Plan so you can update your model within agreed limits, and align with Good Machine Learning Practice.
We review your labelling against FDA requirements for software devices.
We handle FDA registration and listing, and help foreign manufacturers appoint a US Agent.
We help you implement a QMS that meets the FDA QMSR and ISO 13485.
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.
EN 62304 / IEC 62304 - Medical device software lifecycle
IEC 82304-1 - Health software products
IEC 62366-1 - Usability / human factors engineering
ISO 14971 - Risk management for medical devices
ISO 13485 - Medical devices QMS
ISO/IEC 42001 - AI management systems
ISO 9001 - General quality management
