---
title: "Supporting Oncomfort in developing and certifying their ISO 13485 QMS"
description: "QbD Group helped Oncomfort quickly implement and certify an ISO 13485 compliant Quality Management System."
url: https://qbdgroup.com/zh-cn/case-studies/supporting-oncomfort-in-developing-and-certifying-their-iso-13485-qms
type: "Case study"
language: zh-cn
published: 2021-06-30
publisher: "QbD Group"
citation: "QbD Group, \"Supporting Oncomfort in developing and certifying their ISO 13485 QMS\", https://qbdgroup.com/zh-cn/case-studies/supporting-oncomfort-in-developing-and-certifying-their-iso-13485-qms"
---
# Supporting Oncomfort in developing and certifying their ISO 13485 QMS
> QbD Group helped Oncomfort quickly implement and certify an ISO 13485 compliant Quality Management System.

[Oncomfort](https://hypnovr.io/en/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**.

## 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
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Source: https://qbdgroup.com/zh-cn/case-studies/supporting-oncomfort-in-developing-and-certifying-their-iso-13485-qms — © QbD Group. Quote freely with attribution and a link back.