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Technical inspection & certification

Medical Device Quality (ISO 13485)

Quality management is assessed across the medical-device lifecycle, from design and production to distribution and technical support. ISO 13485 certification evaluates the processes, controls and documentation that underpin consistent product quality and regulatory readiness.

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Medical Device Quality (ISO 13485)
Expertise across the Swiss Approval network
Service details

Scope of service

  • 01
    Medical-device quality management against ISO 13485
  • 02
    Design and development controls
  • 03
    Production processes and inspection controls
  • 04
    Storage, shipment and distribution
  • 05
    Installation and technical support
  • 06
    Control of outsourced processes and related services
  • 07
    Risk-based documentation and feedback processes

Who this service is for

For medical-device manufacturers, distributors and organisations providing related services.

Industries

The applicable edition, scheme and accreditation scope are confirmed before engagement.

Network service reference · swissapproval.gr

Related expertise

Technical inspection & certification

EU Notified Body Assessment

For products requiring notified body involvement, the assessment route is coordinated with the relevant Swiss Approval European entity. Work is defined by the applicable legislation, product category and that body's current notified scope.

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