At Healthily, we strive to meet the highest standards in medical safety and pride ourselves in being the first self-care platform to achieve Medical Device Class I status in the EU. But what exactly is a Class I medical device?
Devices that have been certified as Class I are regarded as low risk, and range from bandages to symptom checker platforms like Dot™ – which has been carefully crafted to meet the regulatory criteria for safety, efficacy, and reliability.
Don’t just take our word for it – the Medicines and Healthcare Products Regulatory Agency (MHRA) has certified our platform as a Class I medical device. This means it meets the European Union’s Medical Device Directive.
The commitment to safety doesn’t just stop there. Healthily™ has been working for almost a decade to build the strongest foundations and has Gold Standard Regulatory Credentials.
Mark of quality
The Healthily platform has the Organisation for the Review of Care and Health Apps (ORCHA) Quality Mark. ORCHA ensures that the people behind our products are suitably qualified and granted Healthily a score of 76%, which means it’s Level 4 – the highest level possible.
Independent evaluation
Dot™, our Smart Symptom Checker (SSC) was assessed by Imperial College London’s Self Care Research Unit with the Royal College of General Practitioners (RCGP) and showed the SSC to be 97% safe and subsequent testing based on the model has shown condition accuracy of 72%.
Other safety accolades include:
Our content has received the Patient Information Forum (PIF) TICK, which shows Healthily produces health information using robust production processes and the information is trustworthy.
Our Quality Management System is approved by Reckitt and audited by the UK’s Professional Records Standards Body.
Our products adhere to the following internationally recognized standards:
DCB 0129; Clinical Risk Management: Its Application in the Manufacture of Health IT Systems
ISO 14971 (2019): Medical Devices - Application of Risk Management,
ISO 1485 (2016): Medical Devices - Quality Management Systems
IEC 6266-1: Medical Devices - Application of Usability Engineering
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