成功案例Enhancing data integrity & aseptic manufacturing compliance
Quality Assurance2025年4月7日
QbD Group helped a leading medical tech company improve MDR compliance and enhance aseptic manufacturing for long-term regulatory readiness.
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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.
2021年6月30日1 分钟阅读
OncomfortThis revolutionizing digital therapy combines clinical hypnotherapy and integrative therapeutic techniques through Virtual Reality.
挑战
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.
方法
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.
结果
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
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