Israeli medtech start-up receives European Medical Device Regulation approval
"The sophisticated design of the Sapphire and its accessories enabled us to complete the processes required to meet MDR’s updated safety standards," Eitan Medical VP says.
By Jerusalem Post Staff, March 10, 2021
Eitan Medical's SapphireTM infusion pump (photo credit: Courtesy)
Israeli medtech company Eitan Medical
received EU Medical Device Regulation (MDR) 2017/45 certification for
the newest upgrades to its Sapphire™ infusion pump accessories and
administration sets, the company announced on Tuesday, two months after
receiving FDA approval for its system software Rev15.
The products serve clinicians in hospitals and home care environments across Europe with pain management therapies.
“This
is an important milestone for Eitan Medical, representing our
commitment to meeting the most stringent regulatory requirements. We
prioritized securing MDR clearance early this year, in order to meet the
most stringent up to date standards, continually enhancing quality for
our customers,” said Judith Antler, executive vice president of Quality
Assurance and Regulatory Affairs at Eitan Medical.
"The sophisticated design of the Sapphire and its accessories enabled us to complete the processes required to meet MDR’s updated safety standards," she said.
The
Sapphire’s upgraded Rev15 software, certified by EU MDR, delivers a
simplified workflow, increasing its ease of use including a perineural
route to support a larger range of pain management therapies.
The
software was also simplified to reduce key presses, message prompts and
preset offerings and includes the FasTest PM preventative maintenance
solution, designed for fast and efficient on-site fleet management.
Additionally, the epidural portfolio was updated with NRFit® dedicated connectors.
Sapphire Infusion Setup Training Video, Eitan Medical, Apr 19, 2020
“For over a decade, Eitan Medical has developed innovative,
future-ready infusion solutions. Receiving MDR clearance was a critical
priority for us to ensure that we continue to serve as a reliable
partner to our Sapphire™ customers in hospitals, alternate site,
homecare and pre-hospital settings,” said Roger Massengale, chief
commercial officer of Medication Delivery Solutions.
“Achieving MDR clearance was not only necessary from a regulatory perspective, but demonstrates again the safety of our products," he said. "Clinicians can rest assured that they are delivering optimal care to their patients with our infusion solutions."
MDR
is an expansion of European medical device regulations that emphasizes
transparency, patient safety and post-market surveillance.
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