Audit Preparation
Regulatory and quality audits represent pivotal moments for medical device and in vitro diagnostic manufacturers. Whether conducted by Notified Bodies, Competent Authorities, or internal quality teams, audits determine not only compliance status but also organisational credibility. The MDR and IVDR have heightened scrutiny on manufacturers’ quality management systems, technical documentation, and post-market processes. Even well-prepared organisations face challenges when documentation is inconsistent, personnel are untrained in regulatory communication, or procedures lack clear traceability. Incomplete readiness often results in non-conformities, corrective actions, and potential certification delays that can disrupt business continuity.
Our Audit Preparation services provide a structured, evidence-driven framework to achieve complete audit readiness. We begin with a comprehensive pre-audit review of your QMS, technical documentation, and supporting records. Each element is evaluated against ISO 13485:2016 clauses and MDR/IVDR requirements, with particular attention to areas most frequently examined by auditors; document control, design and development traceability, risk management, CAPA effectiveness, and PMS integration. This diagnostic assessment identifies compliance gaps, procedural inconsistencies, and areas of potential auditor focus.
Following the assessment, we implement a remediation plan that prioritises actions by regulatory significance and audit impact. Our consultants assist with document updates, process refinements, and cross-functional coordination to ensure that all records present a coherent narrative of compliance. Special attention is given to ensuring consistency between the Quality Manual, Standard Operating Procedures, and records generated through daily operations.
We also provide targeted audit training for staff at all levels of the organisation. These sessions focus on preparing personnel to engage effectively during audits, emphasising clarity, accuracy, and confidence in responding to auditor questions. Participants learn how to present evidence, manage document requests, and maintain composure under scrutiny. Training exercises simulate real audit interactions to ensure readiness across departments.
For clients preparing for Notified Body or Competent Authority inspections, we conduct full mock audits replicating regulatory methodologies. These simulations identify residual weaknesses, evaluate team performance, and generate actionable feedback. Each exercise concludes with a detailed audit report that classifies findings by severity and provides recommendations for corrective and preventive actions.
Audit preparation also extends to supplier and subcontractor oversight. We support organisations in qualifying and monitoring their suppliers to ensure that outsourced processes meet the same compliance standards as internal operations. This approach ensures that external partners do not become points of vulnerability during regulatory reviews.
An effective audit preparation process does more than ensure compliance; it strengthens operational control, reinforces accountability, and enhances organisational credibility. By transforming audits from stressful events into predictable, well managed evaluations, we help clients maintain uninterrupted certification and market access.
For further information on how our Audit Preparation services can support your organisation’s compliance readiness and inspection performance, please contact our quality and regulatory assurance team.
