About me

I have a master’s degree in pharmacy.
In more than twenty years of work, I have gained extensive experience in various fields of activity, in the pharmaceutical and healthcare sectors, especially in the field of medical devices and pharmacy, where I have extensive years of experience in the regulatory and supervisory field.
I like challenges that require a broader knowledge and understanding of the situation. I am able to perform several tasks at the same time, connect them and, by thinking about challenges, find innovative solutions. I always like to learn something new. Because I believe that changes in life are the only constant. I can easily adapt to even such a complicated situation.
My professional field is knowledge of legislative regulations and interpretation of regulatory requirements, as well as knowledge of the operation of the medical device market in the Republic of Slovenia and in the European Union.

I acquired competencies in the field of medical devices, as a appointed national expert for the Republic of Slovenia, while working at the national competent authority (JAZMP). I have completed training for the ISO 13485 for auditors. I participated in the adoption of the MDR and IVDR at the European Commission and its implementation in practice. I have been a member of the Medical Devices Coordination Group (MDCG) for both regulations since its establishment and since September 2019. I participated in the CAMD (Competent authority for Medical Devices) and was actively involved in working groups for MDR / IVDR implementation in the European Union regulatory framework. I have the experience as an assessor in designating domestic and foreign notified bodies for medical devices. At the newly established medical device manufacturer, I set up a QMS system in accordance with the standards and updated technical documentation for medical devices and medicines.
Last year, I started working as an external expert collaborator with the Chamber of MedTech Slovenia, which operates within the Chamber of Commerce of Slovenia and is a member of the European association Medtech Europe.

 

I regularly monitor news in the field of medical devices and help you implement them in practice.

Based on the described work experience, I offer you advice on meeting regulatory requirements, interpretation of supervisory requirements and guide you in the requirements for QMS documentation. I give you guidelines for the challenges you face.

I upgrade my expertise with knowledge of agile methods and business modelling (Marketing 3.0).

Contact me for individual advice and I believe I will find the right solutions for you.

Marcia Elena Podboršek

The company

MedDev Rešitve, Marcia Elena Podboršek s.p.

Dragomelj 78A, 1230 Domžale, Slovenia

Phone

00386 41 556 499

Email

info@medical-device.si
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