Senzo Announces ISO 13485:2016 Certification for Its Quality Management System
The ISO 13485:2016 certification confirms Senzo as a leading provider of in vitro diagnostic device development, as it brings its Amplified Lateral Flow (ALF) technology to market
PHILADELPHIA, September 21, 2022 (Newswire.com) - Senzo, an international life sciences technology company developing the world's most accurate point of care diagnostics tests for diseases including COVID-19, HIV, Tuberculosis, Flu, Hepatitis C, and Sexual Health, amongst many others, announced today the receipt of its ISO 13485:2016 certification.
By bringing high-accuracy testing out of the laboratory and to the patient, Senzo will be able to diagnose disease faster and more affordably, enabling better treatment at an earlier stage of illness, thereby improving patient outcomes for millions of people globally.
Achieving the ISO 13485:2016 certification for medical device quality management systems is a key milestone that demonstrates Senzo's commitment to the quality and safety of its products so that they consistently meet customer and regulatory requirements.
"There are currently patients who are not being diagnosed early enough to access the treatment they need when they need it most. Senzo's Amplified Lateral Flow (ALF) tests will bring diagnostics out of the laboratory and directly to the patient, without sacrificing accuracy, diagnosing illness, and enabling treatment at the earliest opportunity. This innovation has the potential to improve treatment outcomes for millions," said Jeremy Stackawitz, CEO of Senzo.
Senzo, which recently announced a $2M Pre-Series A Financing to bring the ALF technology to market, is targeting a commercial launch of its first tests in H1 2023.
About Senzo:
Senzo is an in vitro diagnostics company developing innovative, accurate, and accessible testing products. Senzo was founded with the vision of utilizing novel technologies, with a focus on enhanced sensitivity, to create mobile, point-of-care and self-testing products and devices with the ability to accurately, quickly, and cost-effectively conduct testing where healthcare professionals and patients need it most. Senzo is creating game-changing products and systems which bring testing to the patient, eliminating the need for the current slow, expensive central-lab testing paradigms. With insights generated at the point of care, patients can make better decisions faster, and healthcare professionals can identify life-threatening diseases at an earlier stage, improving treatment outcomes and saving lives. www.senzo.com.
Source: Senzo Health
