Neuronetics, Inc. (NASDAQ:STIM), a commercial stage medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced its certification in two enhanced compliance programs. The Company has received CE Mark Certification for NeuroStar Advanced Therapy under the new Medical Device Regulation (MDR) in the European Union (EU) and the Medical Device Single Audit Program (MDSAP) certification.
“Underscoring our commitment to rigorous regulatory and quality standards, our team has worked tirelessly to achieve these certifications from global regulatory agencies,” said Keith J. Sullivan, President and CEO of Neuronetics. “These enhanced compliance standards lay the foundation for the company’s future as a global organization with the potential to help patients worldwide.”
The EU MDR is a more stringent certification process that replaces the European Medical Device Directive. The process is designed to improve patient safety and ensure the effectiveness and quality of medical devices sold in the EU. It sets rigid requirements for developing, manufacturing, and marketing medical devices. The CE Mark is a symbol that indicates conformity with EU regulations, and it is a mandatory requirement for medical devices to be sold in the EU.
MDSAP certification covers distribution in five countries, including the U.S., Japan, Canada, Australia, and Brazil. Once a company is registered in the country, MDSAP certification streamlines the audit process by allowing medical device manufacturers to undergo a single regulatory audit of their quality management system that fulfills the requirements of multiple regulatory jurisdictions.
For more information about NeuroStar, please visit neurostar.com.
