Software as a Medical Device
regulatory approvals
clinical evidence
economic modelling
IP protection
market access

Hardian is more than just a regulatory consultancy. We are clinically driven, and multidisciplinary meaning that we can cover 100% of what is needed to get your innovation to market.

We’ve brought software and AI devices to market ourselves, and have since helped over 100 companies do the same successfully.


Standard regulatory consultants can only help you with the technical compliance required for software medical devices - we go further and help you with so much more. From clinical investigations, to health economic modelling, IP management and go to market strategy, Hardian is by your side for the whole journey.

Our regulatory consulting services are fully comprehensive. We take companies from idea to commercially viable product, by starting with the Intended Use, all the way to Post Market Surveillance.

We build and maintain Quality Management Systems, collaborate on Technical File construction, develop internal processes for your company to ensure compliance with all applicable ISO and IEC standards, and train your team to take over the reigns so you can pass audit for CE marking and FDA clearances with confidence. Additionally, we advise on best practices for Clinical Evaluations, including Literature Reviews and Clinical Investigations.



Find out more about our regulatory services here.

Hardian is clinician founded, and clinician led. It’s in our DNA. Only by understanding clinical care pathways can a technology be effectively deployed and impactful. 50% of regulatory documentation is clinical after all.

We advise on best practices for regulatory compliant Clinical Evaluations, including systematic Literature Reviews and Clinical Investigations. Additionally, we provide clinical support for Health Economic Modelling and Go To Market Strategy, and help companies apply for grant funding.

Find out more about our clinical services here.

At Hardian we provide full stack Intellectual Property services, from identifying your IP and copyrightable assets, to defining their value, mitigating their risks, and securing patenting and trademarking.

Equally, we help you demonstrate Freedom to Operate by ensuring you are not infringing on the IP rights of others.

Find out more about our IP services here.

Our team of expert market strategists work collaboratively with companies from day one of a market strategy project. We like to meet face to face, hold a workshop to dive deep into your product’s capabilities, claims and positioning. Then we conduct thorough market research on the sector and clinical use case, including identifying key stakeholders and conducting structured interviews. This helps us pinpoint the unmet need, and derive the core value proposition. From there, we work with you to provide recommendations on all aspects of your market entry, from branding and positioning, to pricing and reimbursement.

Our team is multi-disciplinary, so we take a holistic view of your technology, including the regulatory, clinical and health economic aspects to ensure true market viability.

Read a success story with AlphaBiomics here.

Hardian conducts health economic modelling for SaMD and AIaMD products building off well-established principles that have been used for decades in the life sciences and pharmaceutical industries.

Mathematical models incorporating decision tress, Markov scenario modelling and Bayesian reasoning can be combined to produce different types of models. At Hardian we focus on three types of model:



Early models
- to help guide clinical investigation planning

Budget Impact Models (BIM)


Cost Effectiveness Analysis (CEA)



These three types of health economic model are the most commonly used in NICE submissions and payer discussions globally.

Read more about our health economics services here.