Unannounced Audit 2017
In order to ensure continuous compliance with Council Directive 93/42/EEC on medical devices, the European Commission introduced a new regulatory requirement on September 24, 2013, mandating unannounced audits by notified bodies for manufacturers of Class III medical devices.
In line with this requirement, on February 22, 2017, the notified body SGS UK conducted an unannounced audit at Instrumentaria.
The notified body confirmed that all processes were in compliance with the requirements of Directive 93/42/EEC, and that the quality management system was fully aligned with the regulatory requirements of ISO 13485:2012.
