Major Medical Devices - Manufacturing, Legislation, Quality, Certification

2025/2026, Postgraduate studies, Full-time studies

Thematic scope

Design, manufacturing methods, and testing of medical devices; Legal and certification requirements for medical devices; Regulations and certification of medical devices with special characteristics; Impact of medical devices on the human body and the clinical evaluation process; Practical application of ISO 14971, 13485, and 10993 standards in medical device certification.

Who are postgraduate studies aimed at?

The program is intended for engineers, researchers, and other professionals interested in developing their careers in the medical devices sector, including: research engineers and staff of scientific and research institutions specializing in biomaterials, biomedical engineering, materials technology, and related fields; graduates of technical disciplines (e.g., materials engineering, biomedical engineering, mechanical engineering, automation, electronics, chemical technology); employees of R&D, quality, regulatory affairs, and production departments in companies designing and manufacturing medical devices; experts and auditors cooperating with certification and notified bodies; professionals with technical experience seeking to broaden their knowledge of legislative and normative aspects; and specialists considering a career change into the medtech sector.

Head of postgraduate studies

Prof. dr hab. inż. Elżbieta Pamuła, 44-48, epamula@agh.edu.pl

Organizer of postgraduate studies

Prof. dr hab. inż. Elżbieta Pamuła, 44-48, epamula@agh.edu.pl

Contact person

Dr inż. Patrycja Domalik-Pyzik, 37-59, pdomalik@agh.edu.pl

List of courses - Summer semester, 2025/2026 See additional information
Course	Number of hours	ECTS credits	Form of verification	Mandatoriness
Course details Lectures: 25 h Laboratory classes: 5 h Seminars: 10 h ECTS points: 7 Form of verification: Completing the classes Mandatoriness: Obligatory	Lectures: 25 Laboratory classes: 5 Seminars: 10	7	Completing the classes	Obligatory
Course details Lectures: 33 h , including sub-activities: Zajęcia zdalne: 20 h Workshop classes: 7 h ECTS points: 8 Form of verification: Completing the classes Mandatoriness: Obligatory	Lectures: 33, including sub-activities: Zajęcia zdalne: 20 Workshop classes: 7	8	Completing the classes	Obligatory
Sum	80	15

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The module covers the principles of medical device design, manufacturing technologies, and methods for testing mechanical, physicochemical, and functional properties. Participants will also learn about surface modification techniques and their impact on biocompatibility, as well as practical aspects of prototyping and product verification.

This module focuses on current legal regulations, including Regulation (EU) 2017/745 (MDR), classification and qualification of medical devices, and the conformity assessment process. Participants will learn about normative requirements, market surveillance, and the role of national institutions in device certification.

List of courses - Winter semester, 2026/2027 See additional information
Course	Number of hours	ECTS credits	Form of verification	Mandatoriness
Course details Lectures: 15 h , including sub-activities: Zajęcia zdalne: 15 h Workshop classes: 5 h , including sub-activities: Zajęcia zdalne: 5 h ECTS points: 4 Form of verification: Completing the classes Mandatoriness: Obligatory	Lectures: 15, including sub-activities: Zajęcia zdalne: 15 Workshop classes: 5, including sub-activities: Zajęcia zdalne: 5	4	Completing the classes	Obligatory
Course details Lectures: 25 h Laboratory classes: 10 h ECTS points: 6 Form of verification: Completing the classes Mandatoriness: Obligatory	Lectures: 25 Laboratory classes: 10	6	Completing the classes	Obligatory
Course details Lectures: 15 h Workshop classes: 10 h ECTS points: 5 Form of verification: Completing the classes Mandatoriness: Obligatory	Lectures: 15 Workshop classes: 10	5	Completing the classes	Obligatory
Sum	80	15

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This module discusses legal and normative requirements for sterile medical devices, devices containing a medicinal substance, and devices incorporating animal tissue. Participants will learn about documentation procedures and certification processes specific to such products.

The module covers the interaction between a medical device and the human body, the body’s biological response, and methods for assessing biocompatibility in vitro and in vivo. It also discusses the clinical evaluation process, from study preparation to results analysis.

This module focuses on the practical implementation of the requirements of ISO 14971 (risk management), ISO 13485 (quality management system), and ISO 10993 (biological evaluation of medical devices). Participants gain skills in risk analysis, process documentation, and ensuring product compliance with regulatory requirements.