Regulatory Affairs in Practice
From regulatory requirements to market-ready medical devices.
- Length
- 10 blocks
- Workload
- 65 + 65 h
- Completion
- Certificate
- Language
- EN
What you will learn
Regulatory Affairs in Practice takes you through the entire life cycle of a medical device — from the initial intent and classification, through design, risk management, testing and clinical evaluation, all the way to conformity assessment, market placement and post-market obligations.
Across ten connected blocks you will learn to work with the individual parts of the technical documentation, understand their content and prepare them so that they form a consistent, traceable and professionally defensible whole. The course does not explain requirements in isolation — it shows how they interact. You will see, for example, how a change to the intended purpose affects classification, clinical evaluation and labelling, how risks are linked to design requirements, testing and the instructions for use, or how PMS and PMCF feed back into clinical evaluation and risk management.
The goal is not to produce complete technical documentation for a specific product during the course. The goal is to understand its individual parts, and to prepare, review and interconnect them correctly.
- 65 hours of direct teaching (every second Friday)
- Access to specialised study materials
- Practical checklists and template document structures
- University certificate from FMT VSB-TUO
- Case exercises and examples of real regulatory decisions
Course modules
- 01
Placing a medical device on the market
16 October 2026Definition and classification of a medical device, intended purpose, roles of the manufacturer, authorised representative, importer and distributor, national specifics (SUKL — the Czech State Institute for Drug Control, the RZPRO device register, reimbursement).
More details - 02
Technical documentation 1
30 October 2026Structure of the technical file and its links to the GSPR and the QMS, labelling and UDI, content of the IFU, design and development, process validation versus product verification.
More details - 03
Technical documentation 2
13 November 2026Recurrent testing (EN 62353), usability (IEC 62366-1), risk management (ISO 14971), FMEA/PHA/FTA and traceability.
More details - 04
QMS under ISO 13485
27 November 2026Implementing and auditing a QMS, control of documents and records, competence, design, purchasing, production, monitoring, CAPA and internal audit.
More details - 05
Preclinical evaluation
11 December 2026Safety and performance requirements, mechanical, electrical and environmental testing, ISO 10993, sterility and shelf life, test planning.
More details - 06
Clinical evaluation
15 January 2027State of the art and literature search methodology, CER and equivalence, ISO 14155, plan and report, roles of the sponsor, CRO and investigator, data quality.
More details - 07
Conformity assessment
29 January 2027Notified bodies and their audits, choosing the conformity assessment route, registration in the Czech RZPRO register, reimbursement in the Czech Republic and audit preparation.
More details - 08
Post-market phase
12 February 2027PMS and PMCF, vigilance and FSCA, technical safety checks and servicing, UDI and EUDAMED, the role of SUKL, fundamentals of HTA and regulatory strategy over time.
More details - 09
SaMD and cybersecurity
26 February 2027Software as a medical device, IEC 62304, IEC 81001-5-1 and NIS2, SBOM and vulnerability management, post-market monitoring for SaMD and AI.
More details - 10
Device design: construction and materials
12 March 2027Translating clinical intent into design requirements, choosing materials and surfaces, design principles, sterilisation, packaging and service life.
More details
- Regulatory Affairs and Quality Assurance professionals
- Medical device developers and design engineers
- Project and product managers
- Staff of manufacturers, importers and distributors
- Experts from testing laboratories and healthcare providers
- Researchers, academics and start-up team members
- Anyone taking over responsibility for technical documentation or regulatory processes
- 10 teaching blocks
- 65 hours of expert-led teaching (every second Friday)
- 65 hours of guided self-study
- Run: 16 October 2026 - 12 March 2027
- Entirely online — join from anywhere
- Practical case exercises
- Regulatory templates and document structures
- Minimum 80% attendance
- Certificate from FMT VSB-TUO
- Completed secondary education (school-leaving examination)
- Work experience in MedTech or a related field is an advantage
- Reading knowledge of English (standards and literature)
- how to formulate the intended purpose of a medical device correctly
- how to carry out its qualification and classification
- how technical documentation is structured under the MDR
- how to work with the GSPR and link requirements to objective evidence
- how to connect the technical documentation to a QMS under ISO 13485
- how to prepare and review risk management documentation under ISO 14971
- how to bring in usability and human factors under IEC 62366-1
- how to plan preclinical and biological testing
- how clinical evaluation is structured and what evidence must be prepared
- how to choose the right conformity assessment route
- how to prepare for communication with a notified body
- how to set up PMS, PMCF, vigilance and change management
- which specific requirements apply to medical software, AI and cybersecurity
- how construction, materials, manufacturing, sterilisation and packaging shape regulatory strategy
Two different medical devices will accompany you through the whole course. Using them, the lecturers will gradually show how regulatory requirements translate into the individual phases of development and documentation. The same products are used to explain:
- intended purpose and classification
- GSPR and technical documentation
- risk management and usability
- test planning
- clinical evaluation
- conformity assessment
- PMS and PMCF
- change management
As a result you will not only see isolated requirements, but the full regulatory story of a product and the links between individual decisions.
During the course you will become familiar with the structure and preparation principles of documents and outputs such as:
- device description and intended purpose
- qualification and classification rationale
- GSPR checklist and evidence matrix
- structure of the technical documentation
- labelling, instructions for use and UDI data
- risk management plan and report
- FMEA and other risk analysis methods
- usability engineering file
- preclinical testing plan
- biological evaluation plan
- clinical evaluation plan and CER structure
- PMS and PMCF plan
- vigilance and FSCA documentation
- medical software development documentation
- cybersecurity checklist, SBOM and vulnerability management
The goal is not to produce complete technical documentation for a specific product during the course. The goal is to understand its individual parts, and to prepare, review and interconnect them correctly.
From intended purpose to market and back
The individual modules follow the real life cycle of a medical device. As a result you will understand not only the individual requirements, but also their order, dependencies and consequences.
Don't want to take the whole course?
If you do not want or cannot take the whole course, you can complete selected modules only for 750 € incl. VAT per module. After completing the modules you choose, you receive a Certificate of Completion. The full faculty certificate is available only when you purchase the whole course.
Show individual modules