Nightingale Health Asia achieves ISO 13485:2016 certification and completes regulatory readiness to launch its blood testing service in Singapore
Nightingale Health Plc
Press release
14 November 2024 at 9:15 a.m. (EET)
Nightingale Health Plc’s Singaporean subsidiary Nightingale Health Asia Pte. Ltd. (“Nightingale Health”) has been granted ISO 13485:2016 certification. ISO 13485 is the international quality management system standard for the design, production and distribution of medical devices. ISO 13485 is a requirement for medical device distribution in Singapore, and together with the earlier announced Health Sciences Authority approvals, this certification makes Nightingale Health ready to launch its blood testing service in Singapore before the end of the calendar year.
This recognition was granted by an independent certification body after an audit where Nightingale Health’s quality processes were reviewed. This achievement confirms Nightingale Health’s commitment to product and service quality and shows that it adheres to stringent regulatory requirements globally.
To make Nightingale Health’s blood analysis technology available in Southeast Asia, Nightingale Health collaborates with Innoquest Diagnostics, a leading clinical diagnostics service provider in Singapore and a subsidiary of Pathology Asia Holdings. Nightingale Health’s blood testing service will be offered to healthcare providers through Innoquest Diagnostic’s customer network.
“This certification is a very important step for Nightingale Health’s operations in Southeast Asia. I am very proud that we once again demonstrated that we can manage different regulatory processes in different environments efficiently and with excellent results. We are making strong progress and are ready for commercial launch in Singapore before the end of the calendar year”, says Teemu Suna, CEO and Founder of Nightingale Health.
For further information, please contact:
Teemu Suna, CEO
ir@nightingalehealth.com
About Nightingale Health
Nightingale Health’s mission is to build sustainable healthcare and reduce health inequalities. Nightingale Health has developed the world’s most advanced health check that provides risk detection for multiple chronic diseases from a single blood sample. Nightingale’s Health Check can be scaled to entire populations at a low cost, and it can replace many of the current clinical risk assessments. Detecting disease risks on a population level allows for the effective targeting and tracking of health interventions, and better prevention of the onset of chronic diseases. With every sample we help to create a healthier world.
Nightingale Health operates globally with a parent company in Finland and seven subsidiaries in countries such as Japan, the United States, Singapore, and the United Kingdom. Nightingale Health has customers in more than 34 countries in the healthcare and medical research sectors. The company’s technology is being used in many of the world’s leading health initiatives, such as the UK Biobank, and over 600 peer-reviewed publications validate the technology. The company’s Series B shares are listed on the First North Growth Market Finland marketplace. Read more: https://nightingalehealth.com/
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