Case studies
real-world impact, coming soon
Learn how we support healthech innovators to navigate regulation, build compliance, and accelerate their journey to market.
We are currently working with a growing number of healthech innovators across regulatory strategy, quality systems, and market access.
As our projects progress, we will share detailed case studies showcasing the impact of our work.
What to expect
Early-stage setup
From concept to regulatory strategy. Defining pathway, risk framework, and next steps
The Challenge
An early-stage digital health startup had developed a promising AI-driven tool to support clinical decision-making in primary care. However, the team lacked clarity on whether their product qualified as a medical device, what regulatory pathway applied, and how to manage risk appropriately. With limited in-house regulatory expertise, they needed structured guidance to move from concept to a credible development plan.
Our approach
We conducted an initial regulatory feasibility assessment, including product classification under UK MDR and EU MDR frameworks. We worked with the founders to define intended use and refine claims to align with regulatory expectations. A risk-based framework was introduced using ISO 14971 principles, alongside a high-level regulatory roadmap covering key milestones, evidence generation, and conformity assessment options.
We also provided practical guidance on documentation requirements and early-stage quality considerations to ensure regulatory readiness as the product matured.
The outcome
The startup gained a clear understanding of its regulatory obligations, confirming classification as a Class IIa medical device. A structured development and regulatory strategy enabled the team to prioritise technical and clinical workstreams, strengthening their position with investors and partners.
The company progressed confidently into prototype development with a defined pathway to market.
Key insights
- early clarity on intended use is critical to determining regulatory classification.
- integrating risk management from the outset avoids costly rework later.
- a phased regulatory roadmap helps startups align development with compliance requirements.
QMS development project
Building ISO 13485-ready systems. Documentation, processes, and audit readiness
The Challenge
A growing medtech SME preparing for market entry recognised the need for a compliant Quality Management System (QMS) but lacked the internal capacity and expertise to build one aligned with ISO 13485. Existing processes were informal, undocumented, and not audit-ready, creating a risk to future certification and regulatory approval.
Our approach
We performed a gap analysis against ISO 13485 requirements to identify priority areas. Working collaboratively with the organisation, we designed and implemented a tailored QMS, including core procedures for document control, risk management, design and development, supplier management, and post-market surveillance.
We supported the creation of essential templates and records, ensuring usability and scalability. Staff were trained on QMS processes to embed a culture of quality. Finally, we conducted a mock audit to assess readiness and identify any residual gaps before certification.
The outcome
The organisation successfully established a fully documented and operational QMS aligned with ISO 13485. Staff confidence in quality processes increased significantly, and the company entered its certification audit well-prepared.
This foundation not only supported regulatory compliance but also strengthened operational consistency and governance.
Key insights
- a tailored, proportionate QMS is more effective than overly complex systems.
- staff engagement and training are key to embedding quality practices.
- early audit simulation reduces risk and improves certification outcomes.
NHS innovation project
Turning clinical insight into compliant solution. Early evaluation, classification, and pathway planning
The Challenge
An NHS clinical team had developed an innovative solution to address inefficiencies in patient triage pathways. While the concept was clinically valuable, the team had limited experience in translating innovation into a regulated product. Key uncertainties included device classification, evidence requirements, and appropriate routes for adoption within the NHS.
Our approach
We worked closely with the clinical team to clarify the intended purpose and assess whether the solution fell within medical device regulations. A classification and regulatory pathway assessment was conducted, alongside early evaluation of data and evidence requirements.
We provided guidance on usability, safety, and clinical evaluation considerations, and outlined options for pilot studies and real-world evaluation within NHS settings. The project was supported with a clear plan linking regulatory compliance with adoption and procurement pathways.
The outcome
The team developed a clearer understanding of the regulatory landscape and the steps required to bring their innovation forward. A defined pathway enabled them to progress initial evaluation studies and engage with relevant stakeholders, including innovation and procurement teams.
The project transitioned from concept to a structured development initiative with strong potential for NHS adoption.
Key insights
- translating clinical ideas into products requires early regulatory framing.
- alignment between regulatory strategy and NHS adoption pathways is essential.
- early evaluation planning supports both compliance and real-world impact.
Our work (in progress)
We are currently supporting projects across:
- early-stage regulatory strategy
- QMS development and implementation
- clinical evaluation planning
- NHS-led innovation initiatives
We are working with a small number of early partners, offering tailored support in return for the opportunity to develop case studies.
If you’re developing a medical device and want structured, expert support, we’d like to hear from you.
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