Press releases Oct 14, 2021
Fimea inspected Nightingale’s regulatory compliance with the requirements for manufacturer of medical device
Press release, 14 October 2021 at 9:50 a.m. (EEST)
The authority supervising regulatory compliance of medical devices and actors in the industry, Fimea, has as part of its market surveillance inspected Nightingale Health Plc’s (“Nightingale”) regulatory compliance with the requirements for manufacturer of medical device. The inspection included an evaluation of the manufacturer’s compliance with statutory obligations and required quality assurance, including among other things fulfillment of risk management, change management, document management, customer feedback management and control of dangerous situations.
The result of the Fimea inspection was that Nightingale is considered to comply with the requirements for manufacturer of medical device.
In addition to Fimea, Nightingale's operations are regularly supervised and inspected by the National Supervisory Authority for Welfare and Health Valvira, FINAS Accreditation Service and notified body Dekra Certification B.V.
For further information, please contact:
Teemu Suna, CEO
Nightingale Health is a health technology company transforming preventive care. We envisage a world that focuses on keeping people healthy rather than just treating illnesses. By combining our pioneering blood-testing technology and the ability to detect future disease risks, we are creating a world-leading health data platform that enables preventative care with better information. The platform helps people make better personal health decisions and connects the health industry to offer their services for individuals’ preventative needs. By empowering the world with comprehensive health insights, we accelerate scientific discoveries, industry developments and improve personal health for everyone