Practical implication
Establish compliant storage conditions for medical devices and set up a non-conformity management system within 3 months.
The ANSM has ordered the establishment of Ortho Partner located in Montreuil to comply with specific requirements concerning the storage conditions of medical devices and to create a system for managing non-conformities. This action must be completed within a period of 3 months.
What changed: Ortho Partner is required to establish compliant storage conditions for medical devices and implement a system for managing non-conformities, complaints, vigilance, recalls, and withdrawals within 3 months.
Why it matters: This injunction could significantly impact operational compliance and oversight at the specified facility, ensuring that medical products are stored correctly and that non-conformities are managed effectively.
Practical implication: Establish compliant storage conditions for medical devices and set up a non-conformity management system within 3 months.
View original source
- Source: ANSM (France) - News feed
- Published at source: 2026-09-07T00:00:00.000Z
- Discovered by monitor: 2026-09-07T21:36:51.572Z
Published from the regulator source ingestion pipeline after PV impact triage.
