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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.

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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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Wholesale authorisation for medicinal products

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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Certification of GDP Compliance of a Wholesale Distributor

Certificate of compliance with the principles of good distribution practice (GDP certificate).

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Manufacturer's Authorization for drug products for xylometazoline hydrochloride solution 0.1% nasal spray in accordance with standard approval

The manufacturing authorization according to § 13 (1) AMG entitles the holder to manufacture xylometazoline hydrochloride solution 0.1% nasal spray in accordance with standard approval, taking into account Good Manufacturing Practice (GMP).

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Certification of GMP Compliance of a Manufacturer

Certificate of compliance with the principles of good manufacturing practice (GMP certificate).

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