MDR Audit Readiness in 6 Weeks

Industry: MedTech distribution
Company size: approx. 25 employees
Region: Germany
Objective: Implement an MDR-compliant QMS to ensure traceability, documentation and manufacturer audits

Results at a glance
– Manufacturer audit passed in line with MDR Article 14 – no non-conformities
– Significantly reduced effort for traceability and document retrieval
– Faster audit preparation through centralized, structured documentation

Starting point
Daily operations were running – but regulatory risks were increasing.

• Processes had evolved over time but were not consistently documented
• Information was spread across Excel files, Outlook inboxes and paper folders
• Traceability relied on manual, person-dependent effort

Challenge

With increasing MDR scrutiny, pressure from manufacturers intensified.

• Unclear roles and outdated training records
• First structured MDR audits conducted by manufacturers
• A concrete request for CE and UDI documentation of specific batches
  → Evidence could not be provided in a timely manner, delaying release and creating revenue risk

Starting point

Daily operations were running – but regulatory risks were increasing.

• Processes had evolved over time but were not consistently documented
• Information was spread across Excel files, Outlook inboxes and paper folders
• Traceability relied on manual, person-dependent effort

Challenge

With increasing MDR scrutiny, pressure from manufacturers intensified.

• Unclear roles and outdated training records
• First structured MDR audits conducted by manufacturers
• A concrete request for CE and UDI documentation of specific batches
  → Evidence could not be provided in a timely manner, delaying release and creating revenue risk

Solution

Implementation of TRYPTIC QMS (Integrity package) with a clear focus on distributor obligations under MDR Article 14.

Implementation within 6 weeks:

– Current-state analysis and prioritization of all MDR-relevant distributor processes
– Structured mapping of documents, roles and workflows in the QMS
– Employee training and transition into live operation
– Audit simulation to validate readiness for manufacturer review

All evidence was consolidated in a digital MDR distributor file, centrally managed and audit-ready at all times. Regulatory responsibility and final review remained fully with the organization.

Results (after 3 months)
– MDR compliance confirmed: manufacturer audit passed without findings
– More efficient operations: reduced manual effort in goods receipt and traceability
– High responsiveness: documentation immediately available for audit questions
– Operational clarity: clear responsibilities and reproducible processes