About

Part of the University of BOB体育登录网址_欧宝体育官网平台-APP|下载’s School of Healthcare Enterprise & Innovation, Idea-to-Impact works with the BOB体育登录网址_欧宝体育官网平台-APP|下载 Emerging Therapies and Technologies (SETT) Centre at University Hospital BOB体育登录网址_欧宝体育官网平台-APP|下载 NHS Foundation Trust to provide practical regulatory and quality management expertise to MedTech innovators.

BOB体育登录网址_欧宝体育官网平台-APP|下载 mission

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

BOB体育登录网址_欧宝体育官网平台-APP|下载 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.

 

BOB体育登录网址_欧宝体育官网平台-APP|下载 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