ZIEN Medical Enables Faster EU Market Entry with CE Mark for SAM Medical IO Device
ZIEN Medical Technologies, a contract development and manufacturing organization (CDMO) headquartered in Salt Lake City, has announced the successful CE Mark certification under the EU MDR (EU 2017/745) for SAM Medical Products’ intraosseous (IO) access device. This marks ZIEN’s first CE Mark achievement as a legal manufacturer on behalf of a client.
Founded in 2009, ZIEN offers a vertically integrated platform for medical device companies, including design and development, manufacturing, packaging, sterilization, and regulatory services. With EU MDR and MDSAP certifications in place, the company can act as the Legal Manufacturer (LM) or Manufacturer of Record (MoR), providing a streamlined route for market entry. This service model can shave up to two years and over $100,000 from the typical time and cost of bringing a product to market.
SAM Medical, a U.S.-based company specializing in emergency medical devices, partnered with ZIEN to extend access to its IO device across Europe. By designating ZIEN as the MoR, SAM Medical has been able to offload regulatory oversight while maintaining focus on product innovation and commercial expansion.
“This partnership enables our internal teams to focus on expanding our broader product portfolio while ZIEN handles regulatory and engineering support,” said Kyle Sims, Director of Product Development at SAM Medical.
Tim Nieman, CEO of ZIEN, emphasized the broader impact of the collaboration: “The EU MDR has made it harder for innovative devices to reach patients. Our platform is designed to reverse that trend. This CE Mark is more than a milestone — it’s a validation of our model to help medtech companies scale globally, faster.”
With the CE Mark secured, SAM Medical’s IO device will now be available to healthcare providers and patients across the European Union, expanding the company’s international footprint while highlighting ZIEN’s growing role as an accelerator in the global MedTech ecosystem.
