Program Overview

Introduction to the University Program

The university program in question is focused on Medical Devices, covering their manufacturing, legislation, quality, and certification. This program is designed to address the dynamic development of the MedTech sector and the growing demand for specialists who combine technical competencies with practical knowledge of legal and certification requirements.

Characterization of the Studies

The Medical Devices program is a response to the need for professionals who can navigate the complex regulatory environment of medical devices. It combines academic knowledge with practical experience from industry experts, covering the full lifecycle of a medical device, from design and biomaterial selection to manufacturing, testing, biocompatibility assessment, clinical evaluation, quality systems, and certification compliant with the Medical Device Regulation (MDR).

Target Audience

The program is aimed at engineers, research workers, and other specialists interested in developing a career in the medical devices industry. This includes:

• Engineers and researchers in biomaterials, biomedical engineering, materials technology, and related fields
• Graduates of technical fields (e.g., materials engineering, biomedical engineering, mechanical engineering, automation, electronics, chemical technology)
• Employees in R&D, quality, regulatory affairs, and production departments of companies designing and manufacturing medical devices
• Experts and auditors collaborating with certification and notified bodies
• Individuals with technical experience looking to expand their knowledge into legislative and normative aspects
• Specialists considering a career change into the MedTech sector

Program Details

The program is realized in cooperation with CeCert Sp. z o.o., an experienced expert center in the regulation and certification of medical devices. This partnership provides participants with access to current practical knowledge directly related to market and regulatory requirements.

Program Structure

The program is conducted over two semesters and includes 5 thematic modules:

1. Design, manufacturing methods, and testing methods for medical devices
2. Legal and certification requirements for medical devices
3. Regulations and certification of medical devices with special characteristics
4. The impact of medical devices on the organism and the clinical evaluation process
5. Practical application of ISO 14971, ISO 13485, and ISO 10993 norms in the certification of medical devices

Teaching Methods

Classes are conducted in the form of lectures, laboratories, workshops, and seminars, with a strong emphasis on case studies, document analysis, and practical aspects of working with medical devices.

Graduate Profile

Graduates of the Medical Devices program possess specialized knowledge in the design, manufacturing, testing, and certification of medical devices, as well as knowledge of applicable legal regulations and industry norms. They are able to identify legislative requirements, conduct risk analysis, and assess the biocompatibility of medical devices according to current standards, including ISO 14971, ISO 13485, and ISO 10993. Graduates are prepared to work effectively in interdisciplinary teams in the MedTech sector, both in Poland and abroad.

Career Opportunities

The program prepares graduates for work in various departments, including:

• Research and Development (R&D)
• Quality and Quality Assurance
• Regulatory Affairs
• Certification and Compliance
• Research and development units and certification bodies
• Companies designing and manufacturing medical devices

Additional Information

• Duration: 2 semesters (March 2026 - February 2027)
• Form of Study: Postgraduate studies, stationary classes (with selected elements realized remotely)
• Admission Criteria: The condition for admission is having a diploma of completion of at least first-degree studies (Bachelor's or Engineer's degree) or uniform Master's studies, and submitting a complete set of required documents within the recruitment period.
• Tuition Fees: 7000 z (3500 z per semester)

Admission Process

• Application Period: From 1 to 28 February 2026
• Required Documents:
  • Application form
  • Diploma of higher education (for inspection to confirm the copy's compliance with the original)
  • Declaration of familiarity with the Regulations of Postgraduate Studies
  • Proof of payment for the first semester of postgraduate studies, no later than 14 days before the start of classes

This program is designed to equip participants with comprehensive knowledge and practical skills necessary for a successful career in the medical devices industry, emphasizing regulatory compliance, quality assurance, and the ability to work in a rapidly evolving field.