Dermicus achieves ISO 13485 certification: A milestone in commitment to quality and customer satisfaction
From the left: Daniel Eliasson, COO, and Rien De Wachter, Quality and Regulatory Affairs Manager.
25 September 2023
Dermicus (also known officially as Gnosco), digital health company that delivers purpose-built skin solutions, is thrilled to announce a significant achievement in its commitment to quality and customer satisfaction. The company has successfully attained ISO 13485 certification for its Quality Management System (QMS), reinforcing its dedication to delivering high-quality products and services.
ISO 13485:2016 an internationally recognized standard, is tailored for organizations engaged in the design, development, production, installation, and servicing of medical devices. This certification sets stringent requirements for establishing and maintaining a comprehensive quality management system, ensuring the highest levels of safety, reliability, and effectiveness.
“We are proud to have achieved ISO 13485 certification,” said Rien De Wachter, Quality and Regulatory Affairs Manager at Dermicus. “This achievement reflects our commitment as an organization to be able to provide medical devices that meet customer and regulatory requirements and reflects how our entire company has embraced our Quality Management System.”
The adoption of ISO 13485 and our QMS has brought several key benefits for Dermicus. It has streamlined internal processes, ensured continuous improvement, enhanced risk management, and improved our product development lifecycle, ultimately resulting in the delivery of products that meet or exceed the highest quality standards and provide greater confidence in the reliability and safety of our medical devices.
Dermicus’ commitment extends beyond product quality. It also signifies the company’s unwavering focus on customer satisfaction and its pledge to maintain an open and transparent communication with its valued customers.
“We are on a continuous journey with our clients and external stakeholders as we continue to invest in R&D that will require higher levels of regulatory compliance.” added Daniel Eliasson, COO of Dermicus. “Our ISO 13485 certification symbolizes an important milestone in that journey, with more milestones in the near future.”
About ISO 13485:2016 – international standard for medical devices
ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes, is a global standard published by ISO, the International Organization for Standardization, for the management of medical devices and related services. The standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Dermicus, also known officially as Gnosco*, is a digital health company that helps its clients transform the diagnosis and treatment of skin conditions with solutions for teledermatology, telewoundcare and skin imaging. Their mission is to help healthcare providers re-engineer the diagnostic and treatment processes of skin conditions with purpose-built technology and proven implementation methods. Derm Analytics/BDEM-01 as medical devices and the Dermicus platform is flexible and built to be configured to different care settings including hospitals, dermatology practices, primary care centres, pharmacies, nursing homes, visiting nursing. For more information, please visit our website at www.dermicus.com
For more information, please contact
Peter Kinhan, +32 47 680 34 26, firstname.lastname@example.org
Daniel Eliasson, +46 760 405 012, email@example.com
*Gnosco and Dermicus are the same legal entity operating under different trade names. References to ‘Gnosco’ or ‘Dermicus’ in this document pertain to the same company.