Ortoma has been reviewed and received an ISO 13485 certificate. ISO 13485 is a global standard in quality management, which describes the processes and documentation required to supply medical products to the healthcare industry. Intertek, an international accreditation body with 36,000 employees, issued the certificate.
ISO 13485 is based on ISO standard around 9001, but has higher standards of product safety and documentation. ISO 13485 is well established all over the world to approve suppliers of medical devices.
“Now that we have been approved and achieved ISO certification is an acknowledgment that Ortoma live up to the high demands placed on companies that develop and sell products to the healthcare industry. This is also an important step towards CE marking of our first products in implant surgery, “says CEO of Ortoma Bertil G. Larsson.
To further strengthen Ortoma efforts around quality assurance and CE certification, Björn Bergh has been engaged as Quality Manager. Björn Bergh has extensive experience in quality assurance and product certification and he was formerly Quality Manager at Nobel Biocare.
For further information please contact:
Bertil G. Larsson, CEO
Phone: -46 702 99 75 10