What's Happening?
ZIEN Medical Technologies, a Salt Lake City-based company, has achieved its first CE Mark under the EU MDR (EU 2017/745) for its customer SAM Medical Products. This certification allows ZIEN to act as the 'Legal Manufacturer' or 'Manufacturer of Record,' facilitating the accelerated introduction of medical devices to the global market. ZIEN's capabilities include product design, development, manufacturing, and regulatory services, which significantly reduce the time and cost for medical devices to reach the market. SAM Medical Products, known for its emergency medical devices, has partnered with ZIEN to expand its market reach in Europe, particularly for its Intraosseous Access Market products.
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Why It's Important?
The achievement of the CE Mark by ZIEN Medical Technologies is significant as it addresses the increased regulatory barriers posed by the EU MDR, which have previously hindered the introduction of innovative medical technologies in Europe. By reducing the time to market by up to two years and cutting costs by over $100,000, ZIEN enables medical device companies like SAM Medical to expand their product offerings and market presence more efficiently. This development is crucial for the healthcare industry, as it ensures that life-saving medical devices can reach patients more quickly, potentially improving patient outcomes and expanding access to advanced medical care.
What's Next?
With the CE Mark certification, ZIEN Medical Technologies is poised to further its role as a key player in the global medical device market. The partnership with SAM Medical is expected to lead to the introduction of more products in Europe, enhancing the company's market presence. ZIEN will continue to provide regulatory and engineering support, allowing SAM Medical to focus on expanding its product portfolio. This collaboration may inspire other medical device companies to seek similar partnerships to overcome regulatory challenges and accelerate their market entry.
