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
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.
For further information please contact:
DKSH Holding Ltd. Dominique Nadelhofer Manager, Group Media Relations Phone +41 44 386 7228 dominique.nadelhofer@dksh.com | DKSH Switzerland AG Nadine Berdux Brand Champion Phone +41 44 386 7245 nadine.berdux@dksh.com |
About Medinova
With selected healthcare products, Medinova AG has competences in various therapeutic fields, mainly focusing on women’s healthcare and therapeutic skin care. The product portfolio includes a range of prescription drugs (RX), such as Gynoflor and Fluomizin, and over-the-counter (OTC) products, such as Hirudoid and Benocten. Integrated into the network of our parent company DKSH, the leading Market Expansion Services provider with a focus on Asia, Medinova is marketing and distributing products locally and abroad. The regional focus lies on Europe, Asia and selected countries in the Americas as well as Africa, bringing our products via DKSH and further qualified partners to more than 60 countries today.
About DKSH Group
DKSH is the leading Market Expansion Services provider with a focus on Asia. As the term "Market Expansion Services" suggests, DKSH helps other companies and brands to grow their business in new or existing markets. Publicly listed on the SIX Swiss Exchange since 2012, DKSH is a global company headquartered in Zurich. With 780 business locations in 36 countries – 750 of them in Asia – and 30,320 specialized staff, DKSH generated net sales of CHF 10.5 billion in 2016. DKSH was founded in 1865. With strong Swiss heritage, the company has a long tradition of doing business in and with Asia and is deeply rooted in communities and businesses across Asia Pacific.