Deputy Director of Management Systems Assessment, SIQ Ljubljana
I am a deputy director of Management systems assessment at SIQ Ljubljana and since 2009 product manager for medical device certification according to MDD 93/42/EEC and MDR (EU) 2017/745. Involved in medical device certification since 2004. Since 2009 she is a representative of SIQ in notified bodies coordination group and representative in TEAM NB. I am working in the field of certification for 33 years.
I am a SIQ lead auditor (site auditor) for quality management systems (ISO 9001, ISO 13485, MDD, MDR), product reviewer for MDD & MDR technical documentation, final reviewer, decision maker and authorising personnel for MDD & MDR. I am also a lead auditor for some other management systems.
Audit experience: more than 225 audits of ISO 13485, MDD and MDR (QMS and technical documentation assessment of devices for imaging, therapeutic devices, ophthalmology, measuring function, nanotechnology). And more than 150 other audits.
I am a trainer for site auditors and product reviewers at SIQ and presenter at different conferences.
