Tivic Announces Successful Recertification of ISO 13485 Quality Management System and the European Medical Device CE-Mark
February 23 2023 - 9:00AM
Business Wire
Tivic Health® Systems, Inc. (“Tivic”) (Nasdaq: TIVC), 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.
About Tivic
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. For more information visit https://tivichealth.com
@TivicHealth.
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Systems, Inc.’s current expectations and are subject to inherent
uncertainties, risks, and assumptions that are difficult to
predict. Further, certain forward-looking statements are based on
assumptions as to future events that may not prove to be accurate.
Actual results could differ materially from those contained in any
forward-looking statement as a result of various factors. Given the
existence of risks and uncertainties, you are cautioned not to
place undue reliance on such forward-looking statements. For a
discussion of certain risks and uncertainties, and other important
factors, relevant to the company, any of which could cause Tivic’s
actual results to differ from those contained in the
forward-looking statements, see Tivic’s filings with the SEC,
including, its Annual Report on Form 10-K for the year ended
December 31, 2021, filed with the SEC on March 31, 2022, under the
heading “Risk Factors”; its Registration Statement on S-1, filed
with the SEC on October 26, 2022, and amendments thereto under the
heading “Risk Factors”; as well as the company’s subsequent filings
with the SEC. Forward-looking statements contained in this press
release are made as of this date, and Tivic Health Systems, Inc.
undertakes no duty to update such information except as required by
applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230223005391/en/
Media Contact: Kayleigh Westerfield 949-632-3439
Kayleigh.Westerfield@tivichealth.com
Investor Contact: Hanover International, Inc.
ir@tivichealth.com
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