A well-accomplished annual audit in accordance with ISO 13485:2016
SpectraCure AB (publ) announces today that the company has successfully undergone the annual audit according to ISO 13485:2016. The audit, conducted by a notified body, confirms that SpectraCures's quality management system meets the stringent requirements of the international standard.
SpectraCure’s quality management system has undergone the annual ISO 13485:2016 audit. The authorised auditor confirmed that the company's quality management system complies with the requirements of ISO 13485:2016.
"Our goal is to streamline healthcare through focal and minimally invasive treatment, improving the quality of life for the thousands of men affected by prostate cancer. Meeting the stringent requirements is a step towards achieving our goal," comments Acting CEO Masoud Khyyami.
SpectraCure has been certified according to ISO 13485:2016 since March 2022, meaning that the company strictly adheres to the regulations governing medical devices. The certification covers all aspects of the business, including the development, manufacturing, service, and installation of equipment for photodynamic therapy. Certification significantly facilitates the process of obtaining market approval for medical devices globally. The annual audit by a notified body is an essential part of SpectraCures's commitment to continuous improvement and compliance with international standards in medical technology.