ISO 13485
Certified quality for medical devices
We manufacture plastic components to the highest quality standards – reliably, precisely, and certified according to EN ISO 13485. For customers who expect safety and excellence, and for employees who want to take responsibility.
What is EN ISO 13485?
- International standard for quality management systems in medical technology
- Guarantees safety, reliability, and regulatory compliance
- Basis for production-related control and documentation of our products
What are the benefits of this?
Benefits for our customers
- Highest quality: all products are manufactured according to strict standards
- Reliable series production: standardized processes minimize risks
- Traceable documentation: from prototype production to series launch
- Regulatory compliance: EN ISO 13485 as an internationally recognized standard
Benefits for our employees
- Quality-conscious work: taking responsibility for safe products
- Structured processes: clear standards and modern tools
- Further development: training and education in quality management
- Teamwork & innovation: working together on solutions for medical technology
When and how does certification take place?
Our manufacturing processes are regularly audited and adapted as necessary to ensure that all products comply with international quality standards. You can download the current EN ISO 13485 certificate here.
EN ISO 13485
What is EN ISO 13485?
- International standard for quality management systems in medical technology
- Guarantees safety, reliability, and regulatory compliance
- Basis for production-related control and documentation of our products
Benefits
What are the benefits of this?
Benefits for our customers
- Highest quality: all products are manufactured according to strict standards
- Reliable series production: standardized processes minimize risks
- Traceable documentation: from prototype production to series launch
- Regulatory compliance: EN ISO 13485 as an internationally recognized standard
Benefits for our employees
- Quality-conscious work: taking responsibility for safe products
- Structured processes: clear standards and modern tools
- Further development: training and education in quality management
- Teamwork & innovation: working together on solutions for medical technology
Certification
When and how does certification take place?
Our manufacturing processes are regularly audited and adapted as necessary to ensure that all products comply with international quality standards. You can download the current EN ISO 13485 certificate here.
Quality and safety are our top priorities. With EN ISO 13485 certification, we guarantee that our products meet the highest international standards. For our customers, this means reliable, tested quality; for our employees, it means a safe and structured working environment.
Mert Ünal,Head of Quality Management
Additional questions on this topic
EN ISO 13485 ist eine internationale Norm für Qualitätsmanagementsysteme in der Medizintechnik. Sie gewährleistet, dass Medizinprodukte sicher, zuverlässig und nach höchsten Qualitätsstandards hergestellt werden.
Sie garantiert die Produktsicherheit, minimiert Produktionsrisiken und gewährleistet die Einhaltung gesetzlicher Vorschriften – sowohl für Kunden als auch für Anwender.
Alle Kunststoffkomponenten, die wir für medizinische Anwendungen herstellen, werden gemäß den Vorgaben der ISO 13485 produziert.
Kunden erhalten Produkte, die höchsten Qualitätsstandards entsprechen, zuverlässig dokumentiert sind und den gesetzlichen Anforderungen entsprechen.
Die Mitarbeitende arbeiten in einem strukturierten, qualitätsorientierten Umfeld, übernehmen Verantwortung und können ihre Fähigkeiten kontinuierlich weiterentwickeln.
Unsere Prozesse werden regelmäßig auditiert, dokumentiert und kontinuierlich verbessert. Jede Produktionsstufe wird gemäß ISO 13485 überwacht – von der Prototypenfertigung bis zur Serienproduktion.
Ja, unser aktuelles EN ISO 13485-Zertifikat ist auf Anfrage oder zum Download hier verfügbar.