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New Swissmedic Guidance on Medical Device Maintenance – 2025 Edition Now Available

Swissmedic has released the 2025 edition of its Good Practice for the Maintenance of Medical Devices. A summary of what the update changes for healthcare institutions, manufacturers, and service providers.

Date

7. Februar 2025

Tag

Regulatory Updates

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Swissmedic has just released the 2025 edition of the Swiss Good Practice for the Maintenance of Medical Devices (GPI V2)

This updated guidance provides essential recommendations to ensure compliance, patient safety, and the optimal performance of medical devices throughout their lifecycle.


Key updates in the 2025 edition

  • Revised maintenance standards aligned with the latest regulatory requirements

  • Enhanced risk management approaches for maintenance processes

  • Practical checklist to support inspections and internal audits


Healthcare institutions, manufacturers, and service providers can now access the document and integrate these best practices into their maintenance strategies. Find the full document and checklist here.


Ensuring high-quality medical device maintenance is crucial for patient safety and regulatory compliance. Let’s set new industry standards together!

KEY TAKEAWAY

Swissmedic has released the 2025 edition of the Swiss Good Practice for the Maintenance of Medical Devices (GPI V2).

The update aligns maintenance standards with the latest regulatory requirements, enhances risk management approaches for maintenance processes, and adds a practical checklist to support inspections and internal audits. Healthcare institutions, manufacturers, and service providers should integrate these practices into their maintenance strategies.

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