IMed Consultancy provides expert regulatory and quality assurance support for software as a medical device (SaMD), AI as a medical device (AIaMD), and connected digital health technologies. Our team helps innovators and established manufacturers bring medical device software to market with speed, precision, and confidence, ensuring compliance without slowing innovation.
Expert Guidance for SaMD, AI as a Medical Device, and Digital Health
Whether you’re developing an AI-driven diagnostic platform, AI as a medical device (AIaMD) solution, a clinical decision support tool, or a connected monitoring system, IMed Consultancy helps you align with global SaMD frameworks.
Our specialists combine regulatory insight with technical understanding to guide you through every phase of development, from software design and validation to post-market monitoring.
We support:
Balancing Innovation and Regulation
Developing medical device software means balancing rapid innovation with strict compliance requirements. IMed Consultancy bridges that gap, helping digital health teams maintain agility while meeting standards for safety, performance, and traceability.
We work as part of your team, advising on risk classification, lifecycle documentation, and audit readiness. From concept to release, we ensure your software is developed to withstand regulatory scrutiny in the UK, EU, USA, and global markets.
Supporting AI and AI as a Medical Device (AIaMD)
Artificial intelligence and AI as a medical device (AIaMD) bring new opportunities, and new regulatory challenges, for medical device software developers. IMed’s consultants help you interpret guidance from the MHRA, FDA, and European Commission, ensuring your AI products meet evolving expectations for validation, bias, and explainability.
We stay ahead of emerging frameworks for adaptive algorithms and continuous learning systems, ensuring you maintain compliance even as your technology evolves. That’s a necessity for true AI innovation.
Our Software as a Medical Device Expert
Sophie Orme
IMed Consultancy’s specialists blend deep regulatory knowledge with real-world commercial insight. We help clients of all sizes, from growing startups to global manufacturers, accelerate innovation while maintaining the highest compliance standards.
Why Choose IMed Consultancy?
Our clients trust us because we make digital health regulation feel achievable. IMed’s consultants have real-world experience in both technology and compliance, from embedded software to complex AI architectures.
We provide:
Frequently Asked Questions
Building compliant digital health products is complex, and the rules are evolving fast. Here are some of the most common questions clients ask our medical device software consultants.
Software as a medical device (SaMD) refers to software that performs a medical function on its own without being part of a physical device. That includes diagnostic, monitoring, and treatment-planning software that supports clinical decision-making.
If your software is intended to diagnose, treat, or influence patient care decisions, it is likely regulated as a medical device software product. IMed can assess your intended use, determine classification, and guide your approval pathway.
Yes. Our software as a medical device consultancy supports AI/ML developers with performance validation, dataset traceability, and documentation that meets global regulatory expectations.
AI as a medical device (AIaMD) refers to medical device software that uses artificial intelligence or machine learning to perform a medical function, such as diagnosis, prediction, or clinical decision support. These systems are regulated based on intended use, risk, and how the AI model is trained, validated, and updated over time.
Unlike traditional hardware devices, SaMD is entirely software-based, meaning regulatory emphasis falls on lifecycle management, cybersecurity, and algorithmic performance rather than physical design.
IMed Consultancy supports submissions and compliance for the UKCA mark, EU CE marking under MDR/IVDR, and US FDA 510(k) pathways.
Ready to Bring Your Digital Health Product to Market?
IMed Consultancy helps you turn innovative medical device software into compliant, market-ready products. Whether you’re developing your first SaMD or refining an established system, our experts are ready to help.