Everything you need to know about our certifications and product standards.
URSATEC stands for expertise and service in the development, registration and manufacture of innovative products for the global healthcare market.
ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 13485 is a standard that specifies the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
ISO 15378: Quality management systems – Requirements for primary packaging materials for medicinal products (GMP)
ISO 15378 is a standard that specifies requirements for primary packaging materials for medicinal products and medical devices, taking into account good manufacturing practice (GMP).
The wholesale authorisation according to §52 AMG authorises the wholesale of finished medicinal products in accordance with Good Distribution Practice (GDP).
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