Certificate of Semadeni AG
EN ISO 13485:2016 – Medical devices
Quality management for medical-grade plastic parts.
Is Semadeni AG certified to EN ISO 13485:2016?
Yes. Semadeni AG is certified to EN ISO 13485:2016 – certificate no. 17152, issued by QS Zürich AG, valid until 23.02.2028 subject to successful surveillance audits. The certified scope covers: Production and distribution of plastic products for medical devices. The certified site is Ostermundigen (CH).
What it is about
EN ISO 13485 is the standard for quality management systems in the medical device sector. It sets particular requirements for traceability, risk management and documentation across the entire product life cycle.
What this means for you
For you: regulatory-grade manufacturing of plastic parts for medical devices – with the depth of evidence medical technology demands.
Certified scope
Production and distribution of plastic products for medical devices.
What the audit covers
The audit covers risk management, batch-level traceability, cleanliness and contamination control, the control of changes and deviations, and the procedure for corrective and improvement actions. Every production stage within the scope is audited, including document control and training records.
For your procurement
An important distinction: what is certified is our management system for production and distribution – it does not replace the conformity assessment of your finished device. As a supplier we can be referenced in your technical documentation; batch records are provided per project.
Questions about our certificates
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Jagoda Mijac · Head of Quality Management
