HypnoVR obtains ISO 13485 certification
Strasbourg, 14 April 2021, HypnoVR, the European leader in digital therapies for pain and stress management, announces that it has obtained its certificate of conformity to ISO 13485:2016 from the notified body MDC. HypnoVR thus becomes the first company to be certified in its field with its virtual reality medical hypnosis solution.
“Obtaining ISO 13485:2016 certification represents a new key step for HypnoVR as a medical device manufacturer. This certification reinforces the quality management process we have put in place and which is essential to evolve within the regulatory framework of healthcare. This demanding certification also underlines the evolution of the company, which now meets the highest levels of performance, quality and safety. With this certification, we continue to make HypnoVR a reference in the non-drug treatment of pain and anxiety,” says Nicolas Schaettel, co-founder and president of HypnoVR.
Already widely present in anaesthesia and the operating theatre, HypnoVR is constantly developing new applications of its digital therapy for the medical world. HypnoVR software is used beyond the operating theatre in many departments to reduce patient pain and anxiety, but also to manage caregiver stress, with clinically validated therapeutic effectiveness. This certification supports the potential of the solution and broadens the prospects for growth in France and internationally.
“The ISO certification is a real recognition of the investment of the whole team in the structuring of our activity. In addition to being internationally recognised, it is essential for the design of a safe and effective medical device” explain Drs Chloé Chauvin and Denis Graff, co-founders of HypnoVR.
About ISO 13485: 2016
The internationally recognised ISO 13485:2016 standard sets out the requirements for a quality management system specific to the medical device sector.
In the face of regulations that impose increasingly stringent requirements at every stage of a product’s life cycle, including service and delivery. ISO 13485:2016 enables organisations to demonstrate the effectiveness of their quality management processes and implement best practice throughout their operations.