FindOut is certified according to ISO 13485:2016
On 2020-12-17, FindOut took a big step forward by obtaining ISO 13485:2016 “quality management system for medical device manufacturers”. The organisation has during the past 9 months implemented, maintained and worked according to FindOut’s new quality management system.
Certification of ISO 13485:2016 opens up great opportunities for FindOut by being able to launch patient-safe products on the market as the legal manufacturer of medical devices.
– Certification according to ISO 13485:2016 is a must in order for us to carry out our ambitious plans for the company. We have had a steep learning curve during the past 9 months, but we got paid for our effort through the auditor’s comment “you are a small but very powerful company”. I am incredibly proud of what we have managed to achieve in such a short time. We are now recharging our batteries and look forward to the CE-certification of our FindOut CRP Test, says Denise Luxenburg Stuifbergen, CEO of FindOut Diagnostic.
The purpose of ISO 13485:2016 is to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
ISO 13485:2016 is based on ISO 9001 but has higher requirements for formal documentation and specific requirements for product safety.
ISO 13485:2016 certification is obtained through at least 2 approved audits by an authorised auditor, and thereafter both announced and unannounced inspections by the authorised auditor take place at least once a year to maintain the ISO certification.
Denise Luxenburg Stuifbergen, CEO FindOut Diagnostic AB
+ 46 (0) 768 52 44 62, Denise@findout.se
About FindOut Diagnostic AB
FindOut Diagnostic’s vision is to make health data available on the individual’s terms through the development of high-quality diagnostic self-tests for the European market. We have been developing and distributing diagnostic self-tests for home use since 2001. The attitude to what care is is changing as we have become increasingly interested and actively seeking knowledge about our health. Self-tests are a good tool for getting information about one’s health.
FindOut is backed by, among other investors, Add Health Media, which is one of the Nordic region’s largest media houses in health and medicine, as well as running DOCTORN and Praktisk Medicin. Add Health Media invests in e-health start-ups, such as Doctrin, Mindler, Colivia, Medicheck, Remisshjälpen, ScientificMed and Healthmakers.