Services · Quality Management
Medical Device Quality
Management System (QMS)
ISO 13485 is the standard harmonised in the UK and EU, and recognised in the US. We help you build a QMS that achieves certification and works in practice — not just on paper.
Why It Matters
Compliance is not optional.
But it can be efficient.
Medical device companies intending to place products on markets such as the UK, EU and US are required to operate a suitable Quality Management System. ISO 13485 is the internationally recognised standard — and demonstrating compliance is a prerequisite for market access.
Many companies struggle to implement a QMS that satisfies auditors without becoming a bureaucratic burden. XioMed builds systems that are proportionate to your organisation's size and stage — robust enough to pass certification, practical enough to actually use.
Book a Free ConsultationOur Process
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1
Free Initial Consultation Discuss your company, product, and target markets to understand your QMS requirements.
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2
Tailored QMS Plan A custom plan built around your specific company structure, product type, and regulatory scope.
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3
Documentation & Implementation Customisation and implementation of all required QMS documentation with your team.
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4
Training & Audit Preparation Staff training and preparation for Stage 1 and Stage 2 notified body audits.
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5
Certification & Beyond Support through Stage 1 and Stage 2 audits to certification, with ongoing compliance support thereafter.
What We Deliver
QMS Documents & Activities
Every QMS is tailored to your organisation. The following are typical documents and activities delivered as part of an ISO 13485 implementation.
Quality Manual
The top-level document defining your QMS scope, structure, and how it meets ISO 13485 requirements.
- QMS scope and exclusions
- Organisational context & responsibilities
- Process interactions & structure
- Policy statements
Standard Operating Procedures
Clearly written SOPs covering all required QMS processes — practical, auditor-ready, and aligned to your actual operations.
- Document & record control
- CAPA & non-conformance management
- Internal audit programme
- Management review process
Templates & Forms
A complete library of controlled templates and forms to support consistent implementation of your QMS processes.
- CAPA and NCR forms
- Audit checklists & reports
- Change control records
- Supplier evaluation forms
Multi-Market Compliance
QMS frameworks designed to satisfy ISO 13485 for UK and EU markets, with alignment to US FDA 21 CFR Part 820 where required.
- ISO 13485:2016 compliance
- UK MDR 2002 alignment
- EU MDR / IVDR alignment
- FDA 21 CFR Part 820 alignment
Certification Preparation
Hands-on support preparing your team and documentation for notified body and approved body certification audits.
- Stage 1 audit readiness review
- Stage 2 audit preparation
- Mock audit & gap analysis
- Audit finding response support
Sustaining Support
Continuous support to maintain certification and keep your QMS effective as your organisation and product portfolio evolve.
- Surveillance audit preparation
- QMS updates for regulatory changes
- Internal audit programme management
- Ongoing advisory & consultancy
Deep Audit Experience
40+ Notified Body Audits.
Real-world expertise.
Our principal consultant has participated in over 40 EU Notified Body and UK Approved Body QMS audits, acting as lead auditee in more than 20. This depth of hands-on experience across the planning, implementation, certification, and ongoing maintenance of ISO 13485 and FDA-compliant QMSs enables start-ups and scale-ups to achieve certification efficiently, pragmatically, and with confidence — while aligning with product development, regulatory submission, and market launch timelines.
Ready to implement your QMS?
Talk to us about your company, product, and target markets. We'll scope a pragmatic path to ISO 13485 certification.