Michael Barbella, Managing Editor04.24.23
Tivic Health Systems Inc. has received ISO 13485 recertification as well as 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,” Tivic CEO Jennifer Ernst said. “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.
Tivic is a commercial-phase health technology company delivering non-invasive bioelectronic treatments that provide consumers with a choice in the treatment of inflammation and certain other related conditions.
"These recertifications support our goals to grow the product pipeline in bioelectronic medicine and expand market access,” Tivic CEO Jennifer Ernst said. “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.
Tivic is a commercial-phase health technology company delivering non-invasive bioelectronic treatments that provide consumers with a choice in the treatment of inflammation and certain other related conditions.