About
Our mission
We support medical device innovators by:
- simplifying compliance
- ensuring patient safety
- 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 analysis | Risk management | QMS development and documentation |
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| Implementation planning | Innovation evaluation | Clinical evaluation |
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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
School of Healthcare Enterprise and Innovation
Alpha House
Enterprise Road
Chilworth
Southampton SO16 7NS