Company faced an impending recertification audit processes, fragmented documentation, and a disengaged internal auditor cohort.

Completely redesigned the internal audit programme using risk-based sampling aligned to ISO 9001 and ISO 13485. Designed and updated procedures. Led full migration of controlled documentation into SharePoint with automated workflows and version control.

• Recertification achieved with zero major non-conformities
• Internal audit completion rate increased from 61% to 98%
• Documentation retrieval time reduced by 73%
• New internal auditor training programme embedded across organisation

SaMD company developing design and prototypes needed robust quality controls, documentation discipline and audit readiness ahead of certification in a highly regulated environment.

Established ISO 13485-aligned QMS with specific focus on software design controls, risk management and IEC 62304 processes. Created living templates, traceability matrices and version-controlled SharePoint libraries. Trained internal teams and led gap closure through to successful certification preparation.

• ISO 13485 certification achieved with zero major non-conformities
• Design control and prototype documentation now fully traceable and audit-ready
• Internal capability built — teams now self-sufficient on CAPA and risk files
• Accelerated path from prototype to regulatory submission