Medical Device Consulting · Cambridge, UK

Bring your device to market with confidence.

XioMed provides specialist quality, regulatory and product development support to MedTech companies — from early concept through commercial scale-up and beyond.

ISO 13485 & EU MDR / IVDR Compliant frameworks built in
Full Lifecycle Support Prototype through to post-market
UK & International Start-ups to established organisations
Free Initial Consultation No obligation — talk to us first

What We Do

Expert support across the full device lifecycle.

We tailor every engagement to your stage of growth, regulatory environment, and commercial objectives. We are supported by a network of associates enabling us to identify the right expert for every challenge.

01 — Product Development

Product Development

Structured support from concept to verified, validated product. We bring rigour to your development process without slowing you down.

  • Project management & planning
  • Requirements definition & traceability
  • Risk management (ISO 14971)
  • Verification & validation protocols

02 — Quality Management

Quality Management Systems

Build a QMS that satisfies auditors and works in practice. We design for your scale, team, and regulatory scope — not a generic template.

  • ISO 13485 QMS creation & implementation
  • Certification preparation & audit support
  • US FDA 21 CFR Part 820 alignment
  • QMS gap analysis & remediation
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03 — Regulatory Affairs

Regulatory Compliance

Clear, practical pathways through EU MDR, IVDR, and beyond. We identify what is required and build the evidence to demonstrate it.

  • Device classification & intended use definition
  • Applicable regulations & standards identification
  • Technical file & documentation support
  • Notified body liaison preparation

04 — Investment & M&A

Due Diligence

Technical and regulatory due diligence for investors and acquirers. Understand the compliance and development risk before you commit capital.

  • QMS & regulatory maturity assessment
  • Technical risk identification
  • Portfolio regulatory landscape review
  • Remediation roadmap & cost modelling
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Why XioMed

Pragmatic expertise.
Commercial awareness.

Founded in 2022 by Alan Finnerty and based in Cambridge, XioMed works with start-ups, scale-ups and established organisations across the MedTech sector, both in the UK and internationally.

We are not generalist management consultants. Our consultants have hands-on experience supporting organisations across the full product lifecycle — and we understand that investor timelines and clinical milestones don't wait.

More About Us
Pragmatic & proportionate

Advice scaled to your stage — not one-size-fits-all compliance theatre.

Embedded, not detached

We work alongside your team — not above it or at arm's length.

Commercially aware

We understand investor timelines and the real cost of regulatory delay.

Associate network

Access to specialists across every MedTech discipline when you need them.

Ready to move forward?

Let's talk about your device, your stage, and how we can help — no obligation.