About

Part of the University of Southampton’s School of Healthcare Enterprise & Innovation, Idea-to-Impact works with the Southampton Emerging Therapies and Technologies (SETT) Centre at University Hospital Southampton NHS Foundation Trust to provide practical regulatory and quality management expertise to MedTech innovators.

Our mission

To support medical device innovators with expert regulatory guidance by simplifying compliance, ensuring patient safety, and accelerating the delivery of transformative healthcare solutions.

Our services

We provide practical support to help innovators meet essential safety, quality, and performance standards for medical devices. Including:

Gap Analysis

  • Baseline assessment against ISO 13485 and UK/EU MDR: Identify compliance gaps specific to your device lifecycle.
  • Prioritised action plan with timelines: Structured roadmap to close gaps efficiently.

Risk Management

  • Device-specific hazard analysis and risk–benefit evaluation: Ensure safety and performance throughout development.
  • Traceability and integration: Link risks to usability engineering and post-market surveillance plans.

QMS Development & Documentation

  • Tailored Quality Management System solutions: Designed for your device type and regulatory obligations.
  • Documentation support: SOPs, work instructions, and templates aligned with ISO and MDR requirements.

Implementation Planning

  • Structured certification readiness plan: Milestones and timelines for audits and regulatory submissions.

Innovation Evaluation

  • Early-stage device feasibility review: Technical, clinical, and regulatory considerations.
  • Regulatory pathway mapping: Advice on classification, conformity assessment, and approval strategy.

Clinical Evaluation

  • Evidence planning for your device: Define clinical data needs based on intended use and risk class.
  • Preparation of Clinical Evaluation Reports (CERs): Compliant with MDR and relevant guidance.

Who we support

MedTech start-ups

Innovative early-stage companies aiming to bring new medical technologies to market quickly and cost-effectively.

University spin-outs

Academic teams and research groups transitioning prototypes into regulated, investor-ready products.

SMEs expanding into new markets

Established manufacturers scaling operations, adapting to new regulations, and entering global markets.

NHS-led projects

Clinical teams and healthcare innovators developing compliant solutions to meet unmet patient needs.

Independent innovators

Individuals or groups with early-stage concepts seeking regulatory guidance and feasibility support.

 

Our values

  • Clinical credibility first — Built on NHS experience and academic excellence.
  • Regulatory mastery — From classification to approvals, we guide every step.
  • Impact-oriented partnerships — We deliver solutions that matter for patients and the system.
  • Transparent collaboration — We work openly with clients, partners and stakeholders.
  • Regional strength, national reach — Rooted in Wessex, operating at UK scale.

Enquire

Share details about your device, current documentation, and timelines, and we’ll propose the right-sized scope tailored to your needs. Please contact i2i@soton.ac.uk to get started. 

People, projects and publications

People