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.

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 is an international standard for quality management systems in medical technology. It ensures that medical products are manufactured safely, reliably, and to the highest quality standards.

It guarantees product safety, minimizes production risks, and ensures compliance with regulatory requirements—both for customers and users.

All plastic components that we manufacture for medical applications are produced in accordance with the specifications of ISO 13485.

Customers receive products that meet the highest quality standards, are reliably documented, and comply with regulatory requirements.

Employees work in a structured, quality-oriented environment, take on responsibility, and can continuously develop their skills.

Our processes are regularly audited, documented, and continuously improved. Every stage of production is monitored in accordance with ISO 13485—from prototype production to series production.

Yes, our current EN ISO 13485 certificate is available on request or can be downloaded here.

1zu1direkt

arrow_outward