Tivic Announces Successful Recertification of ISO 13485 Quality Management System and the European Medical Device CE-Mark
Wednesday, March 01, 2023
Tivic Health® Systems, Inc., a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today announced it has received recertification of ISO 13485, the international standard for medical device quality systems. The company also announced the recertification of ClearUP under the European Union Medical Device Certificate (CE-Mark).
"These recertifications support our goals to grow the product pipeline in bioelectronic medicine and expand market access,” said Jennifer Ernst, CEO of Tivic. “Congratulations to the team for successfully achieving these recertifications.”
ISO 13485 is an international standard for quality management systems (QMS) and applies to medical device companies involved in designing, manufacturing, and commercializing medical device products. ISO 13485 has been harmonized as a basis for the implementation of quality management methods into government regulations on medical devices in countries around the world, including the European Union.