Basics for Medical Device Advisors: Regulatory requirements according to MPG
In the function as a medical device advisor, you perform a responsible activity that carries legally defined rights and obligations in Austria. These national requirements remain as essential components of the new Medical Devices Act (MPG).
In this basic course for medical device consultants, you will deepen your knowledge of the essential nationally and internationally valid legal foundations.
According to the MPG, manufacturers or a person or body appointed by them are obliged to provide regular training for medical device advisors (including proof of training). We support you in this!
After successfully passing the online examination, you will receive an en.co.tec certificate of participation.
- The Austrian Medical Devices Act (MPG)
- Requirements for medical device advisors
- EU regulations for medical devices and in-vitro diagnostics (MDR and IVDR)
- CE marking
- Classification of medical devices and IVD
- Legal aspects of marketing & sales
- Vigilance and Post Market Surveillance
- Definitions and quality criteria
- Case studies
- Early bird (up to 4 weeks before the seminar): Euro 480,- (excl. VAT)
- Standard (4 to 2 weeks before the seminar): Euro 530,- (excl. VAT)
- Last Minute (less than 2 weeks before the seminar): Euro 560,- (excl. VAT)
- incl. seminar documents as PDF and a certificate of participation.
DI(FH) Dr. Andreas Böhler, MLBT
Managing Director R’n’B Consulting GmbH, Lecturer University of Applied Sciences Upper Austria – Software Lifecycle Processes / Operating Systems & IT Security, Expert for Medical Software (EN 62304, EN 62366, IEC 82304-1), Quality Management (EN-ISO 13485), Mobile Health (EN 62304, IEC 82304-1) and Audits (according to EN ISO 19011)
All you need for our ONLINE seminars is a laptop with camera and microphone. Our eLearning platform works on all operating systems in a web browser (e.g. Firefox, Safari or Chrome). You will receive the seminar documents and the link to the virtual seminar room in time by email. The seminar will be interactive – similar to a face-to-face seminar – i.e. you can ask your questions to the lecturer, there will be practice examples and also the possibility to exchange ideas with the other participants.
Click here for online registration.
For questions: email@example.com or +43 1 8863491