QbD Group helped Oncomfort quickly implement and certify an ISO 13485 compliant Quality Management System.
This revolutionizing digital therapy combines clinical hypnotherapy and integrative therapeutic techniques through Virtual Reality.
Despite having developed a beautiful new technology, the company lacked sufficient internal resources and technical knowledge on the ISO 13485 standard.
Oncomfort asked QbD for advice and support to quickly implement and certify a new ISO 13485 Quality Management System.
Quality by Design provided a flexible team of consultants to write and implement procedures in compliance with ISO 13485.
We also trained Oncomfort employees and supported them in all facets of managing a Quality Management System.
With our expert knowledge and support, Oncomfort was able to establish a functioning and certified ISO 13485 Quality Management System.
This new QMS paves the way for Oncomfort to develop more innovative devices, access new markets in the future, and help patients all over the world.
The strong point of QbD Group is to have a helicopter view of the Quality Management System, looking at all different corners.
Frédéric Heraly
QbD Group
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