Medical Devices and IVDs

• ISO 13485 Lead Auditor services
  We can provide independent supplier and internal audit programmes from a certified ISO 13485 Lead Auditor, including audit readiness support.
• QMS development & optimisation
  Design and implementation of ISO 13485-compliant systems for manufacturers, including start-ups.

• Provision of documented procedures compliant with ISO 13485, UK MDR & EU MDR & IVDR.
• Assessment and update of existing documentation to address regulatory gaps or audit findings.
• Structured support for technical documentation.

Notified Body & UK Approved Body readiness

Pre-assessment support, mock audits, and gap closure activities; practical support to prepare teams, documentation, and evidence packs; root cause analysis, CAPA development, and effectiveness review.

Fractional Quality / Regulatory support
Fractional Quality & Regulatory support when you need it.

Supplier & subcontractor oversight
Audit and qualification support for critical suppliers and service providers.

Change & transition support
Trusted support through growth, change, and regulatory transitions.