Medical Device Regulatory Compliance Auditing

Service summary

A scoped review of selected medical device processes against identified regulatory requirements. The audit examines organisational responsibilities and the evidence supporting defined lifecycle and post-market activities.

The service highlights observed gaps for management consideration. It does not grant market access, product registration, notified-body approval or other regulatory conformity status outside a separately authorised programme.

Key objectives

• Assess selected device regulatory controls
• Examine traceability and role responsibilities
• Evaluate complaint and post-market evidence
• Identify compliance documentation gaps

Methodology

A defined requirement matrix is applied to selected devices and processes, with the organisation’s regulatory role and target markets explicitly recorded.

• Confirm devices, markets, organisational roles and assessment criteria.
• Review registrations, responsibilities and relevant technical or quality records.
• Select lifecycle activities, complaints and change events.
• Trace identification, supplier controls and applicable documentation evidence.
• Examine reporting, vigilance and post-market processes within scope.
• Evaluate discrepancies and management follow-through.
• Report observed gaps without implying regulatory product approval.

Key outcomes

References: [G04]

• Scoped device compliance report
• Role and traceability findings
• Post-market process evidence
• Requirement-linked documentation gaps