We Attended the International Conference in Russia

Author: SIQ SIQ Ljubljana representatives introduced the general requirements of the medical directive. On July 18 and 19 2018, an international conference about the EU medical directive for medical devices manufacturers took place in Moscow. The conference was organized by our Russian partner, Haensch развитие качества. The purpose of the conference was to familiarize the participants with the requirements of the...

We are Dedicated to Continuous Training

Author: Miloš Seražin The quality of performing a management system assessment depends on the integrity of the auditor, their professionalism, independence, and diligence. To be able to meet the expectation of the client, usually heads of organizations, the auditor must know the assessment criteria very well in order to objectivelly evaluate the assessment proof. Therefore, we expect the auditor to be knowledgeable of the activity which they asses,...

Preparing for the Future

Author: Marjeta Tušek Jelenc At the start of May 2017, two new regulations on medical devices, MDR and IVDR, were published in the Official Journal of the European Union, and they became effective in all EU members at the end of May 2017. A three-year transitional period applies for Regulation (EU) 2017/745 on Medical Devices (MDR), replacing the Directive on Medical Devices (MDD) and the Directive on Active Implantable Medical Devices (AIMD). A five-year...

Knowledge for assessing medical devices

Author: Ana Pribaković Borštnik, MSc. In September 2013, the European Commission laid down new requirements for the qualification of personnel at notified bodies for medical devices under MDD 93/42/EEC. Notified bodies had to obtain additional knowledge and experts. In the last two years, the European Commission conducted assessments of bodies notified under Medical Devices Directive (MDD) 93/42/EEC, taking into account new requirements as laid down by Commission Implementing...