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Certifications and product standards

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

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.

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ISO 9001: Quality management systems – Basic requirements

ISO 9001 is a standard that specifies requirements for quality management systems.

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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).

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For data protection reasons, the following official certificates are not available for public download:

  • Wholesale Distribution Authorisation acc. section 52 of the German Drug Law (AMG)
  • Certificate of GDP Compliance of Wholesale Distributor
  • Manufacturing Authorisation acc. sec. 13 para 1 of the German Drug Law (AMG) for Xylometazoline Hydrochloride 0.1% Nasal Spray (Standard Marketing Authorisation)
  • Certificate of GMP Compliance of a Manufacturer

We will be pleased to provide these documents upon request. Please feel free to contact us directly.