CUSTOMER
Oncomfort is an innovative company developing digital sedation devices. Digital Sedation™ is a completely new method for relieving patients’ pain and anxiety before, during, and after medical procedures.
This revolutionizing digital therapy combines clinical hypnotherapy and integrative therapeutic techniques through Virtual Reality.
CHALLENGE
Quickly implement and certify an ISO 13485 compliant QMS
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.
Sounds familiar? We can help.
The strong point of QbD is to have a helicopter view of the Quality Management System, looking at all different corners.
APPROACH
Flexible support and QMS training
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.
RESULTS
A solid, future-proof QMS
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.
Contact us
Need help in bringing your medical device to market?
We can support you from concept to launch in the full lifecycle. Read here how we can help or contact us directly.
Thinking about setting up a Quality Management System?