About

Our mission

We support medical device innovators by:

  1. simplifying compliance
  2. ensuring patient safety
  3. accelerating the delivery of transformative healthcare solutions

We are part of Southampton’s School of Healthcare Enterprise & Innovation (HEI). Working alongside us at University Hospital Southampton is the Southampton Emerging Therapies and Technologies (SETT) Centre. Our teams dynamic expertise allows us a 360 view of the industry. We expertly provide healthtech innovators practical quality management and regulatory guidance.


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Our services

We help innovators meet essential safety, quality, and performance standards for medical devices. Our services include:

Gap analysisRisk managementQMS development and documentation
  • 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
  • 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
  • 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 planningInnovation evaluationClinical evaluation
  • structured certification readiness plan
  • milestones and timelines for audits and regulatory submissions
  • early-stage device feasibility review
  • technical, clinical, and regulatory considerations
  • regulatory pathway mapping.
  • advice on classification, conformity assessment, and approval strategy
  • 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

Healthtech 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.

 

People, projects and publications

People

Connect with us

We welcome your enquires

Share details about your device, current documentation, and timelines, and we’ll propose the right-sized scope tailored to your needs.

School of Healthcare Enterprise and Innovation
Alpha House
Enterprise Road
Chilworth
Southampton SO16 7NS

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Open 9am - 5pm