Medical Device Consulting · Cambridge, UK

Bring your medical device to market with confidence.

XioMed provides specialist product development, regulatory and quality support to MedTech companies — from startup, 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 — delivering expert, pragmatic support that reduces cost and complexity.

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 QMSR (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 and based in Cambridge, XioMed works with startups, scale-ups and established organisations across the MedTech sector, both in the UK and internationally — as well as the investors who back them.

We are not generalist management consultants. We bring expert, pragmatic support across the full product lifecycle — and we understand that cost, speed and compliance are not mutually exclusive.

More About Us
Trusted

We give honest, independent advice. Even when it's not what clients want to hear.

Pragmatic

Proportionate solutions built around your stage, your product, and your budget.

Collaborative

Ad-hoc project support or embedded in your team — we flex to fit your organisation.

Commercial

We understand that speed matters and cost is real. We work to your timeline, not ours.

Ready to move forward?

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