Practical Regulatory Affairs (MedTech)

VŠB - Technical University of Ostrava

Dates of the course

Start:
09.10.2026
End:
19.02.2027
Venue:
Ostrava, VŠB - Technická Univerzita Ostrava
Course fee:
54666.00 CZK

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Overview:

VŠB - Technical University of Ostrava

Faculty of Materials Science and Technology

Field of study:
Engineering, manufacturing and construction n.e.c.
Number of credits:
5
Course length:
130 hours
Assessment type:
Problem based learning, Marked assignment, Written examination, Project work, Quiz
Teaching language:
Czech

Course description:

Regulatory Affairs in Practice (MedTech) translates MDR/IVDR and related standards into day-to-day operations. It is delivered by practitioners with proven conformity assessment experience, audit exposure and hands-on technical documentation work; teaching is grounded in real workflows and audit-ready templates. Structured into logical blocks, the course covers device definition and classification, roles of economic operators, technical documentation and GSPR traceability, QMS ISO 13485, risk management (ISO 14971) and usability (IEC 62366-1), pre-clinical and clinical requirements (incl. ISO 14155), conformity assessment, and national specifics (RZPRO, reimbursement, competent authority context), as well as UDI/EUDAMED. A dedicated stream addresses SaMD (IEC 62304, IEC 81001-5-1), cybersecurity and NIS2. The pedagogy is application-first: case-based tasks, audit-readiness, and robust post-market processes (PMS/PMCF, vigilance, advertising, change control). Responding to clear market needs—rapid regulatory change, a shortage of skilled RA/QA professionals, and pressure to reduce time-to-market—the course equips participants to lead compliance across the full medical device lifecycle.

Course content:

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