Regulatory Consulting for
AI and Machine Learning Medical Devices
BioVision helps manufacturers of AI and Machine Learning based medical devices meet the specific regulatory requirements of the FDA and the EU.
AI devices raise unique questions - how do you validate a model that learns and changes over time, and how do you keep it compliant after launch? Our AI regulatory experts answer exactly these questions.
What makes AI/ML devices a regulatory challenge
Traditional regulation assumes a device is fixed at the point of approval. AI/ML devices can be adaptive, data-dependent, and continuously improving - which is why regulators have developed dedicated frameworks. Manufacturers must address:
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SaMD classification - is your software a regulated medical device, and at what risk class?
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Algorithm validation - demonstrating performance, generalizability, and freedom from bias across real-world data.
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Change management - how the model is updated without re-submitting each time.
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Transparency and human oversight - required by both FDA expectations and the EU AI Act.
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FDA's approach to AI/ML-based Software as a Medical Device, including the Predetermined Change Control Plan (PCCP) that lets you pre-authorize defined model updates.
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Good Machine Learning Practice (GMLP) principles.
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EU MDR 2017/745 as it applies to software and AI.
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The EU AI Act, which classifies many medical AI systems as “high-risk” and adds obligations on top of the MDR.
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Determining whether your software qualifies as a regulated device.
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SaMD risk classification under FDA and EU rules.
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Building a Predetermined Change Control Plan (PCCP).
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Aligning your validation and data governance with GMLP.
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Mapping overlapping MDR and EU AI Act obligations into one compliance plan.
The frameworks we work with
How BioVision supports your AI device
Frequently Asked Questions
Is my AI software a medical device?
If your software is intended to diagnose, treat, prevent, or monitor a medical condition, it is likely a regulated medical device (Software as a Medical Device, or SaMD). BioVision can assess your specific intended use.
Can I update my AI model after approval without resubmitting?
With a Predetermined Change Control Plan (PCCP), you can define in advance the types of model changes you intend to make and how you will validate them — allowing certain updates without a new submission. We help you design a PCCP the FDA will accept.
Does the EU AI Act apply to medical devices?
Yes. Many AI-based medical devices are classified as “high-risk” under the EU AI Act, which applies in addition to the MDR. Manufacturers must satisfy both. BioVision maps the overlap so you meet all requirements with one coordinated effort.