ECA Medical Achieves CE Mark
ECA Medical Instruments has gained CE mark designation for its single-procedure precision surgical instruments and kits in the European Union (EU). Headquartered in Newbury Park, Calif., ECA makes single-procedure, torque-limiting and fixed-driver surgical instruments and procedural kits for the cardiac rhythm management (CRM), cardiovascular, neuromodulation and orthopedic implant markets. In January, ECA became registered with the U.S. Food and Drug Administration as a Class 1 medical device company.
The CE Mark was granted following a comprehensive audit of the company’s quality management systems, processes and validations. G-Med North America, a division of certification and auditing company LNE/G-Med in France, performed the evaluation.
“Achieving the CE mark will accelerate adoption of our single-procedure instruments and procedural kits across the EU medical implant community,” said John Nino, ECA’s president and CEO. “Our EU based CRM and neuro customers have added assurance we meet EU wide directives while our existing and new orthopedic implant customers will gain access to new ECA instruments and kits tailored for their medical devices and surgical procedures.”
ECA’s portfolio of disposable torque-limiting and fixed-driver surgical instruments and multi-instrument surgical kits used to secure screws, fasteners and connectors are purchased and used by clients that develop pacemakers, defibrillators, ventricle assist devices and most types of orthopedic implants including spine, small bone, extremities, trauma, cranial-maxillofacial, knee, hip, shoulder and general reconstruction products. The company makes products that are available off-the shelf, but also provides customization services.