Guaranteeing patient safety: digital therapies of the same quality and reliability as all medical devices

At HypnoVR, our commitment to a rigorous and responsible approach to quality reflects our drive to create world-class medical devices that offer innovative solutions to meet the needs of their users, thereby helping to improve healthcare in a sustainable way.

A changing regulatory environment

In the healthcare sector, medical devices play a crucial role, offering a range of solutions for diagnosing, preventing, monitoring and treating illness, injury and disability.

Some of these devices, such as HypnoVR, are considered low risk (Class I) to patients under European Union rules (Regulation (EU) 2017/745). Although the rules for these devices are less strict, it is still very important to ensure that they meet certain standards. This means creating a technical file that follows European Union rules and implementing a quality management system. This guarantees that the product is safe, works well, satisfies customers and complies with current regulations.

Unlike higher-risk devices, low-risk devices do not need to be assessed by a specialist body. A simple declaration of conformity signed by the manufacturer is enough to guarantee that the product is safe and works as it should.

Quality at HypnoVR

Despite the absence of any obligation, HypnoVR has deliberately chosen to submit the quality management system for its virtual reality hypnosis software to ISO 13485:2016 certification. HypnoVR is the only French therapeutic virtual reality company to have obtained this standard from a notified organisation (an independent organisation specialising in the assessment of medical devices). This choice reflects the company’s determination and commitment to comply with the most stringent standards to ensure the safety and well-being of patients.

HypnoVR combines virtual reality with innovative software, offering a cutting-edge approach to medicine. Although these technologies are still in the regulatory structuring phase, it is crucial to ensure that they are implemented with extreme precision. Their medical use requires not only perfect knowledge of current standards, but also constant monitoring to anticipate future regulatory developments.

The aim is clear: to guarantee safety and efficacy for patients and all users.

Beyond regulatory requirements: our commitment to responsible and sustainable quality in our medical devices

HypnoVR does not simply claim compliance with the minimum regulatory requirements applicable to it. The company strives to go further, finding meaning in the implementation of these requirements, to ensure the lasting impact of its medical devices.

Implementing an ISO 13485:2016-compliant quality management system and complying with Regulation (EU) 2017/745 requires cross-functional involvement, involving every department in the company. Formalising and monitoring all processes helps to structure activities and facilitate collaboration between the various teams. Even if it requires a significant investment to set up, the long-term benefits in terms of optimisation, capacity for improvement, quality, safety and customer satisfaction are more than worth it.

HypnoVR is firmly committed to a rigorous quality approach in order to produce cutting-edge medical devices that provide innovative solutions to users’ needs, thereby contributing to sustainable improvements in healthcare.

Patient safety and satisfaction at the heart of our strategic decisions

The strategic choice to implement ISO 13485:2016 and Regulation (EU) 2017/745 is based on our values such as transparency of information, listening carefully to customer feedback and customer and patient satisfaction. Placing the patient at the heart of care is a fundamental ambition for the company. By focusing on the safety, performance and quality of its medical devices, HypnoVR is embodying its philosophy of putting patient safety first, in line with the ISO 13485:2016 approach, rather than focusing primarily on productivity and operational costs, as ISO 9001:2015 would suggest.

Product traceability also plays an essential role in facilitating after-sales service and ensuring effective management of any device recalls. As a result, every decision taken by HypnoVR is guided by a responsible, quality-focused vision, aimed at creating medical devices that meet patients’ needs while guaranteeing their safety and satisfaction.

A long journey to ensure compliance and reinforce the quality of its medical devices

To comply with ISO 13485:2016 and Regulation (EU) 2017/745, HypnoVR adopted a step-by-step approach and called in an external expert. Thanks to its agile development approach, the company is aiming for ISO 13485:2016 certification in 2021. The appointment of Dr Chloé Chauvin as Quality Manager ensures constant attention to the patient’s point of view and rigorous clinical validation of the product thanks to her medical expertise.

With the entry into force of Regulation (EU) 2017/745 in May 2021 and its desire to constantly develop its products in terms of both uses and regulatory destinations, the company has recruited an engineer dedicated to quality and regulatory issues. The challenge is to innovate while complying with a restrictive and changing regulatory environment that is not always adapted to the specific characteristics of our products. The success of our projects lies in the education and communication we have developed between our technical, regulatory and sales teams, to ensure that requirements are applied intelligently, fairly and flexibly. Today, we are taking advantage of the structuring brought about by the regulations to develop our innovations more effectively and give our teams greater visibility, while retaining a high degree of agility.

Thanks to this considered approach and strong internal cooperation, HypnoVR is positioned as an innovative company that places quality, safety and compliance with standards at the heart of its medical devices.

Improving care through high-quality medical devices

To date, HypnoVR has received feedback from over 120,000 patients, testifying to the positive impact of the device. With increasing use of the device, the expectations of users and patients are constantly evolving, both in terms of context of use and performance.

These opportunities for innovation are a source of inspiration for HypnoVR, which has embarked on the development of its class IIa medical device, HypnoVR Biofeedback, building on the foundations of its already well-established product, HypnoVR.

However, this quest for an ever more complete, high-performance product means that we have to meet stricter regulatory requirements. HypnoVR is taking up this challenge with enthusiasm, benefiting from its experience with HypnoVR, the growing skills of its teams, and the robustness of its quality management system.

Join the movement!

More than 350 institutions are already using HypnoVR to improve their patients’ experience of care.