Oncomfort receives ISO 13485:2016 certification Organization – 2021-05-20
Brussels, 20 May 2021 - Oncomfort, 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.
What is ISO 13485:2016
The standard for quality management systems in the medical device industry, designed to ensure the provision of products and services that meet customer and regulatory requirements. More info on https://www.iso.org/standard/59752.html
Oncomfort, founded in 2017 and based in Belgium, develops Digital Sedation™, a drug-free therapeutic solution to relieve patients' pain and anxiety during medical procedures. Digital Sedation™ combines clinical hypnotherapy and integrative therapeutic techniques through Virtual Reality.
Oncomfort's Sedakit™, for performing Digital Sedation™ therapy sessions, is already compliant with the IEC 60601-1-2 technical standard (for electro-medical devices) for use in medical environments such as operating theatres, imaging rooms and radiation treatments. The Sedakit™ software and therapeutic modules are recognised as marked CE Class I medical equipment, confirming that the solution is compliant with European Union legislation and proven effective by numerous clinical studies.
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