Tivic Health® Systems, Inc. announced it has received recertification of ISO 13485, the international standard for medical device quality systems. 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.