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Medinova awarded medical device ISO certification

Medinova has achieved an important development step in upgrading its GMP-certified quality management system (QMS) and implementing the ISO 13485 principle. The expansion to the medical devices sector allows the company to now offer the whole range of healthcare products and services. Medinova is a Swiss specialty pharma and over-the-counter drug company with a focus on women’s health and therapeutic skin care, owned by DKSH.

Media Release

Medinova awarded medical device ISO certification

Medinova has achieved an important development step in upgrading its GMP-certified quality management system (QMS) and implementing the ISO 13485 principle. The expansion to the medical devices sector allows the company to now offer the whole range of healthcare products and services. Medinova is a Swiss specialty pharma and over-the-counter drug company with a focus on women’s health and therapeutic skin care, owned by DKSH.

Zurich, Switzerland, November 3, 2017 – The well-established Swiss healthcare company Medinova has implemented a new quality standard for the medical devices sector. In addition to its Swiss pharma license, Medinova’s good manufacturing practices (GMP) are now comprehensively documented with the internationally-recognized quality management principles of ISO 13485. This achievement allows Medinova to develop, manufacture, control and distribute both medicinal products and medical devices (CE mark). The upgraded GMP and ISO certified system will further support Medinova’s commitment to offer high quality products, competent services and products to physicians, pharmacies, drugstores, patients and consumers.

 

The ISO 13485 standard specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer needs and applicable regulatory requirements.

 

Medinova was founded in Zurich in 1945 and is part of the DKSH Group. The company sells medical products to the Swiss and international pharmaceutical markets, with a special focus on women’s health and therapeutic skin care. Some of the flagship brands include Gynoflor, Fluomizin, Hirudoid and Benocten. Medinova is well-known for its Swiss-quality standard in wider parts of Europe and Asia.

 

“ISO 13485 gives us an exciting opportunity to develop our presence in the medical devices sector, increase our overall portfolio offering towards our partners and customers and strengthen the state-of-the-art quality management system within our company,” said Frank Buennig, Managing Director, Medinova AG and DKSH Switzerland AG.