据该企业介绍，克罗地亚DnA Technologies d.o.o.寻临床试验研究、医疗设备生产合作伙伴。 该公司提供的信息如下：
The company is interested to find partners in international markets, specifically foreign companies needing clinical research services and those interested in joint production of medical devices in the EU (Croatia), as well as sales of drugs and medical devices.
Services and cooperation offered would be best suited for small to medium sized companies in third markets (outside EU) that wish to sell their products to EU market and need a partner to help them navigate the necessary documentation and clinical research, according to EU standards.
Global players in the medical devices sector are already set with new EU regulations, EU production and distribution, however smaller producers, only starting their export to EU, would benefit from services DnA Technologies d.o.o. offers.
ABOUT THE COMPANY
Company DnA Technologies d.o.o. is a full-service Contract Research Organization (CRO), established in Croatia in 2019, licensed by Croatian Ministry of Health and HALMED (regulatory Agency in Croatia) according to EU regulation. Employees of the company have 23 years of relevant experience as well as references of successful cooperation with global brands and producers in the medical sector. (For more details about the company, their scope of business and references, please see PPT attached.)
COOPERATION WITH DnA TECHNOLOGIES D.O.O.
Due to the new EU Medical Device Regulation (EU MDR) all non-EU manufacturers of medical devices are obligated to meet all necessary EU standards and conform their product to EU regulations before placing the product on the EU market. Additionally, the non-EU companies (manufacturers) must do obligatory clinical trials (Post-Marketing Surveillance or PMS) once a year.
The relevant bodies in the EU that can provide needed research and issue necessary documents for export from third countries to EU are called notifying bodies. Company DnA Technologies d.o.o. is registered as a notifying body for the EU market.
The certificates and medical documentation provided by DnA Technologies d.o.o. are equally valid from any notifying body in EU, but the company can offer competitive prices (up to 50% lower than France, Italy, or Germany) for their services, due to good cooperation with local hospitals and relevant medical institutions in Croatia.
Main benefits of cooperation with DnA Technologies d.o.o. are faster service and competitive prices for: certification (medical device assessment); medical device safety; and market registration, as well as distribution of products.
Contact person: Mr. Siniša Žanetić
E-mail: dna@dnatech.eu
Web address: https://dnatech.eu/
