ZIEN Medical Technologies has obtained its first CE mark for SAM Medical Products, under the European Union Medical Device Regulation (EU MDR).
SAM Medical Products specialises in devices for emergency medical procedures, including fracture management and haemorrhage control.
The company has entered the intraosseous access market to enhance patient care during emergencies.
With a presence in the US, Canada, and other regions, SAM Medical aims to expand into Europe.
Through its partnership with ZIEN, SAM Medical leverages regulatory support to focus on product distribution while ZIEN handles engineering maintenance.
SAM product development medical director Kyle Sims said: “ZIEN’s role as Manufacturer of Record allows us to expand our engineering and product support capacity by transitioning the regulatory and technical oversight of this strong IO product line to their team.
“This partnership enables our internal teams to focus on building out the broader SAM Medical portfolio and gives us a scalable path to deliver more patient solutions as we grow our market presence.”
Based in Salt Lake City and established in 2009, ZIEN is a contract design and manufacturing organisation (CDMO) for medical devices.
The company offers services including product design, manufacturing, packaging, and regulatory support.
ZIEN’s role as a Legal Manufacturer or Manufacturer of Record enables it to expedite the market entry of innovative technologies.
With EU MDR and MDSAP certifications, ZIEN can reduce the time to market for medical device companies from over two years to under one year.
The capability, combined with packaging and sterilisation services, provides significant cost and time efficiencies.
ZIEN CEO Tim Nieman said: “ZIEN has for over 16 years been serving our customers as an integrator of services allowing speed to market for medical devices.
“The EU MDR has resulted in increased barriers to the introduction of innovative technologies, stifling technology and causing supply bottlenecks.
“ZIEN is pleased to once again be able to help our customers break through these barriers to provide care solutions that might otherwise not reach patients.”
“Our partnership with SAM Medical allows us to bring the benefits of the SAM Medical IO products to patients in the EU that have to date been unable to have access to this product.”
