Oncomfort receives ISO 13485:2016 certification

ncomfort, the leader in Digital Sedation™, a digital therapy to relieve patient anxiety and pain, today announces that it has obtained the ISO 13485:2016  certification by certification company DARE!! Services. This certification confirms that Oncomfort manages the design, manufacturing and distribution of its Digital Sedation™ medical device and its Sedakit™, in its quality management system according to the latest regulatory requirements in the medical field.

Oncomfort is developing the Sedakit™ that delivers the Digital Sedation™ therapeutic treatment to relieve patients` pain and anxiety during medical procedures without drugs. Digital Sedation™ is a therapeutic medical device developed by Oncomfort, which combines clinical hypnotherapy and integrative therapeutic techniques through virtual reality.

"We are very proud to obtain ISO 13485 certification, which represents a major milestone for Oncomfort! Since the creation of the company, Oncomfort has chosen the pathway towards the development of an advanced medical device, in view of the promising future that Digital Sedation™ brings for patients and healthcare professionals. This certification represents an important guarantee of quality for our customers and users as well as for our technology and business partners," says Mario Huyghe, CEO of Oncomfort. He adds, "The work of our teams is dedicated to better manage patient pain and anxiety and the Sedakit™ will set a new standard in healthcare. Oncomfort as a fully certified medical device manufacturer sets the new industry standard."

"This certification demonstrates the quality of the processes that structure Oncomfort`s medical device development and manufacturing, representing an important recognition of the quality and expertise of the team. ISO 13485 certification is a cornerstone of the company`s innovation strategy." confirms Frédéric Heraly, Quality & Regulatory Manager.