Integrum receives ISO 13485 certification confirming its robust quality management system
Mölndal, Sweden, October 17th, 2022 – Integrum (publ) (Nasdaq First North Growth Market: INTEG B) today announced that the company has received ISO 13485 certification for medical devices from BSI Group the Netherlands B.V. The certification is an external validation of Integrum’s long-term efforts to secure a high level of internal quality control.
ISO 13845 is an international standard designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. The ISO 13485 certificate confirms that Integrum’s quality management system meets the most current regulatory requirements for the medical device industry.
“Having a best-in-class quality management system is fundamental in our ongoing international expansion. This certificate is yet another proof that Integrum has well-established processes in place to meet regulatory requirements in all parts of the world,” comments Rickard Brånemark, CEO of Integrum.