Supporting Oncomfort in developing and certifying their ISO 13485 QMS

Oncomfort

Quality Assurance

Medical Devices

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About Oncomfort

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.

1

Challenge

2

Approach

3

Result

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.

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.

Result

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.

The strong point of QbD Group is to have a helicopter view of the Quality Management System, looking at all different corners.

Frédéric Heraly

Quality Regulatory Manager at Oncomfort

Get in touch

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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?

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