In the timeframe that I worked for Cook Medical, I was an observer during conduction of Internal Audits. I supported audit team during the preparation by preparing the nessesary documents. Likewise I supported and participated in the post-work by preparing the audit report for the de-briefing of the schedualed audit based on the follow-up on finding.

My support was based on having an oversight of regulatory compliance within the Quality Management System (ISO 13485, MDD 93/42/EEC, FDA 21 CFR, Part 11 and FDA 21 CFR, Part 820)

Throughout my time at Medidee, I participated in a number of projects that affected all aspects of MDR compliance.

Among other things, some of my tasks included compliance with national rules for registered products in EU countries as well as classifying products according to Annex VIII from MDR. I also had the task of updating QMS in relation to ISO EN 13485: 2016.

I have gained a basic knowledge of the following medical device standards:

ISO EN 13485:2016

ISO EN 14971:2009

ISO EN 11608-1

- IEC 60601

As part of my work in Siemens Healthcare A/S, I stood for the continuously updating and vigilance to secure that we as a firm was compliant with the national and international recruitments and laws for safe handling of medical devices including in vitro. I had the responsibility for knowledge dissemination to customers of medical devices and reporting events to the authorities.

As part of my work as a sales consultant for Tupperware Scandinavia.
I was responsible for arranging and organizing each product demonstration.
By continuously putting my self in a learning situation I expanded my product knowledge and was thereby able to give my customers and individual guidance that fitted there needs.

By doing so I continuously expanded my clientele and my abilities to disseminate in a structured knowledge-based performance.