Audry Kaune (COO) and Tim Horeman (CTO) signing CE documentation
Surge-on Medical has achieved a great milestone this week: The Steerable Punch for knee arthroscopy has been registered and is recognized with the CE mark for Class I medical devices. Thanks to this achievement, the product can now be freely marketed anywhere in the European Union and commercially reinforced worldwide.
This has been a thrilling journey for Surge-on Medical. Of course, this mark did not come lightly, as detailed protocols had to be implemented to affirm the quality of our innovative instrument.
Outstanding team effort
Surge-on Medical’s COO, Audry Kaune, oversaw the entire certification project, and made it her priority to ensure that no detail was overlooked. Under her supervision, the technical and regulatory departments aligned their efforts toward the development of all required documentation so that all processes were completed according to the applicable standards.
She counted on support from regulatory experts, as well as the whole Surge-on Medical team, which was crucial to successfully compiling the technical dossier in time for a registration under the MDD regulation.
“It is a great satisfaction for me to see this CE registration process concluded. We all worked very hard for several months to prepare our company for this moment,” said Audry. “Even though it was my responsibility to bring this task to a successful completion, I wouldn’t have been able to do so without the tireless support of our team and advisors. This process proved our ability to deliver a high-quality and regulatory compliant product to the market.”
An ongoing process
However, the regulatory efforts don’t stop with this CE Class I registration. Surge-on Medical is committed to maintaining the quality of its instruments and to continuing to improve them to provide a better experience for surgeons and patients. In her role as regulatory leader, Audry Kaune will keep all processes sharp and CE compliant, while she sets her sights on a new target: CE registration for an upcoming generation of arthroscopic and laparoscopic instruments.
If you’ve been waiting to purchase a Steerable Punch, now is the time to contact Surge-on Medical to pre-order the CE-marked device.