Professional knowledge
At the comprehension level:
1. Fundamentals of anatomy, physiology, and pathology.
2. Medical technologies.
3. Use of medical devices/ equipment/ systems in diagnostics, treatment, and therapy.
4. Physical principles of the operation of medical devices/ equipment/ systems.
5. Medical physics.
6. Fundamentals of biophysics and biomechanics.
7. Physical energy effects (mechanical waves, sound waves, electrical and magnetic fields, electromagnetic waves, light, ionizing radiation, etc.) on biological tissues.
8. Fundamentals of anatomy, physiology, and pathology.
9. Medical technologies.
10. Physical principles of the operation of medical devices/ equipment/ systems (physiological measurement devices, imaging equipment, therapeutic equipment, hospital equipment).
11. Fundamentals of technical mechanics.
12. Fundamentals of material resistance and elasticity theory.
13. Fundamentals of technical thermodynamics.
14. Theoretical fundamentals of electrical engineering.
15. Fundamentals of electronic circuit calculations.
16. Fundamentals of radiation physics.
17. Fundamentals of medical physics, biophysics, biomechanics.
18. Physics and effects of hazardous factors (mechanical waves, sound waves, electrical and magnetic fields, electromagnetic waves, light, ionizing radiation, etc.) on biological tissues.
19. Fundamentals of electrical safety of medical devices/ equipment/ systems.
20. Fundamentals of radiation safety.
21. Technology for manufacturing medical devices/ equipment/ systems.
22. Metalworking technology.
23. Technologies of non-metallic materials.
24. Technologies for manufacturing personalised products.
25. Technological cycle.
26. Cycle of the manufacturing of innovative products.
27. Organisation of manufacturing processes, types of manufacturing.
28. Business economics.
29. Fundamentals of medical physics, biophysics, biomechanics.
30. Physics and effects of hazardous factors (mechanical waves, sound waves, electrical and magnetic fields, electromagnetic waves ionizing radiation, etc.) on biological tissues.
31. Fundamentals of electrical safety of medical equipment.
32. Fundamentals of radiation safety.
33. Framework for certification and monitoring of medical devices in Latvia and the European Union.
34. Procedures for registering new medical devices.
35. International standards regulating the operation of medical devices.
36. Medical technologies.
37. Physical principles of the operation of medical devices/ equipment/ systems.
38. Hospital equipment.
39. Use of medical equipment and systems in diagnostics, treatment, and therapy.
40. Fundamentals of metrology, measurement technique.
41. Dosimetric, radiometric, and spectrometric measurement methods and equipment.
42. Principles of experimental activity.
43. Quality system framework, quality assurance, quality control.
44. Vigilance system.
45. Implementation of a quality assurance system at the company.
At the application level:
1. Classification of medical devices.
2. Structure of medical devices/ equipment/ systems.
3. Parameters describing the operation of medical devices/ equipment/ systems.
4. Fundamentals of physical modelling.
5. Performance and documentation of physical measurements (including dosimetric, radiometric, and spectrometric measurements).
6. Planning of an experiment.
7. Data acquisition and processing techniques.
8. Mathematical modelling methods.
9. Fundamentals of conducting a numerical experiment, verification of models and results.
10. Machinery elements, design of mechanical structures.
11. Technical methodology. Metrology of medical devices/ systems.
12. Electronic elements in the design of electronic functional schemes.
13. Design of control elements and systems of equipment, fundamentals of equipment automation.
14. Calculations of machinery elements, including the durability and strength of parts.
15. Calculations of dimension chains.
16. Calculations of heat exchange processes.
17. Electrical engineering calculations.
18. Electronic circuit calculations.
19. Calculations of the control functions of automated systems.
20. Methods for ensuring the safety of medical devices/ equipment/ systems.
21. Methods for ensuring electrical safety of medical devices/ equipment/ systems.
22. Design and calculations of radiation protection elements and installations of medical devices/ equipment/ systems.
23. Civil defence measures in healthcare institutions.
24. Calculations of the modes for manufacturing mechanical parts.
25. Control of automated (CNC) machine tools.
26. Rapid prototyping technologies, including 3D printing technologies.
27. Technology for manufacturing electronic and control units.
28. Calculations of prime cost of the manufacturing of a product.
29. Calculations of prime cost of the operation of a product.
30. Methods for ensuring the safety of medical devices/ equipment/ systems.
31. Methods for ensuring electrical safety of medical devices/ equipment/ systems.
32. Design and calculations of radiation protection elements and installations of medical devices/ equipment/ systems.
33. Fundamental documents prescribing the procedures for monitoring medical devices (EU regulations, Cabinet Regulations of the Republic of Latvia).
34. Classification of medical devices in accordance with the categories specified in laws and regulations.
35. Preparation of applications for the registration of medical devices.
36. Medical device vigilance system.
37. Structure of medical devices/ equipment/ systems.
38. Parameters describing the operation of medical devices/ equipment/ systems.
39. Methods for testing the functionality of medical devices/ equipment/ systems.
40. Dosimetric, radiometric, and spectrometric measurement methodology.
41. Planning of measurements.
42. Data acquisition and processing techniques, calculation of measurement uncertainty.
43. Radiation safety quality programme and its elements.

General knowledge
At the concept level:
1. Employment relationship.
At the comprehension level:
1. Fundamentals of engineering drawing.
2. Fundamentals of standardisation.
3. Scientific research methods.
4. Organisation of clinical research.
5. Financial planning of research.
6. Social and political structure of society.
7. Social diversity and equality. Intercultural interaction.
8. Role of public organisations.
9. Basics of business management.
10. Basics of personnel management.
11. Basics of project management.
12. Rights, obligations, and responsibility of the employer and the employee.
13. Levels of social dialogue and basic principles of establishing a social dialogue.
14. Working conditions and human health as a condition of quality of life.
15. Possibilities and potential risks of information technologies.
16. Personal data protection.
17. Planning and adoption of decisions.
18. Fundamental principles of public speaking and presentation.
At the application level:
1. Standards for drawing up design documentation (ISO, IEC).
2. Use of design software.
3. Development and approval of research protocols.
4. Processing of research data.
5. Preparation of reports and publications.
6. Scientific and medical ethics.
7. Time planning.
8. Applied communication.
9. General and professional ethics.
10. Time planning.
11. Applied communication.
12. General and professional ethics.
13. Presentation of technical information.
14. Personnel training.
15. Laws and regulations in the field of labour law, labour protection, environmental protection, and civil defence. Culture of interpersonal interaction.
16. Internal rules.
17. Drawing up of documents.
18. Applied computer graphics.
19. Security of electronic information.
20. Information technologies for data processing, analysis, and management.
21. Basic principles of cooperation in the digital environment.
22. Self-assessment techniques.
23. Planning of education, career, and progress of work.
24. Time planning techniques.
25. Adequate general and professional vocabulary.
26. Functional grammar.
27. Professional terminology.
28. Fundamentals of intercultural communication.
29. Argumentation techniques.

Professional skills and attitudes
1. To be aware of trends in the development of medical devices/ equipment/ systems.
2. To analyse the operating principles and structure of medical devices/ equipment/ systems.
3. To understand the impact of medical devices/ equipment/ systems on
4. living organisms.
5. To determine the parameters of medical devices/ equipment/ systems critical for
6. evaluating the functionality of equipment.
7. To compare the parameters of the medical devices/ equipment/ systems with market analogues.
8. To identify the risks associated with the medical devices/ equipment/ systems to be designed, and understand related requirements and specific applications.
9. To use mathematical and physical modelling
10. to assess the physical and energetic effects of medical devices/ equipment/ systems on biological tissues, biocompatible materials, and the human body as a whole.
11. To develop conceptual solutions for medical devices/ equipment/ systems.
12. To develop
13. technology for connections and components of medical devices/ equipment/ systems (including data acquisition and management subsystems).
14. To select appropriate construction materials
15. for medical devices/ equipment/ systems/.
16. To take into account potential harmful effects on the human body when developing medical devices/ equipment/ systems.
17. To develop the necessary schemes and diagrams for calculations.
18. To perform engineering calculations by using computer technology and design software and numerical evaluation of the parameters of devices/ equipment/ systems and their connections and parts.
19. To verify the computerised calculations by using simplified calculation methods.
20. To identify the potential risks of using the medical devices/ equipment/ systems to be designed and evaluate the conditions and safety aspects of using equipment and instruments.
21. To comply with the requirements of laws and regulations regarding the structural safety of medical devices/ equipment/ systems.
22. To select the technical solutions for medical devices/ equipment/ systems that ensure the protection of the personnel and patients.
23. To formulate labour protection and radiation safety requirements for work with the medical devices/ equipment/ systems to be designed.
24. To determine civil defence measures for work with the medical devices/ equipment/ systems to be designed.
25. To make well-founded choices of manufacturing methods and technologies suitable for the production of medical devices/ equipment/ systems.
26. To develop
27. technology for the assembly of medical devices/ equipment/ systems.
28. To develop
29. technology for connections and components of medical devices/ equipment/ systems.
30. To develop methodology for
31. testing and functional verification of medical devices/ equipment/ systems.
32. To calculate
33. the prime cost of the operation and manufacturing of medical devices/ equipment/ systems.
34. To identify the risks of using medical devices/ equipment/ systems subject to surveillance.
35. To assess the potential harmful effects on the human body, conditions for the use of equipment, and safety aspects.
36. To assess the impact of the use of medical devices/ equipment/ systems on the environment and society.
37. To incorporate elements and subsystems ensuring the electrical safety, radiation safety, protection against hazardous substances, fire safety, and explosion protection of the patient and operator in the plan for the placement of medical devices/ equipment/ systems subject to surveillance.
38. To participate in the development of labour and radiation safety instructions for use of medical devices/ equipment/ systems subject to surveillance in collaboration with labour and radiation safety specialists,
39. including by adapting the manufacturer’s safety instructions.
40. To identify the category of the medical devices/ equipment/ systems subject to surveillance, and understand related requirements and specific applications.
41. To comply with the requirements of laws and regulations regarding the operational safety of medical devices/ equipment/ systems.
42. To develop
43. user instructions for medical devices/ equipment/ systems.
44. To test the functionality and assess the performance of medical devices/ equipment/ systems in conformity with the manufacturer’s instructions, quality management system requirements, and requirements of laws and regulations, where necessary.
45. To carry out or organise the maintenance and repair of
46. medical devices/ equipment/ systems in conformity with the manufacturer’s instructions and quality management system requirements.
47. To perform dosimetric, radiometric, and spectrometric measurements.
48. To develop dosimetric, radiometric, and spectrometric measurement protocols. To document the results of dosimetric, radiometric, and spectrometric measurements.
49. To comply with the requirements and procedures specified in the implemented quality assurance programme of the company.
50. To participate in the development of a quality assurance programme, including a radiation safety quality assurance programme, for medical devices/ equipment/ systems.
General skills and attitudes
1. To prepare technical documentation (technical descriptions, technical drawings, sketches, and other graphic materials in accordance with the current standards ISO, IEC, etc. for designing graphic material of projects), including by using design software.
2. To be well-versed in research methods.
3. To choose a research topic relevant to the professional activity and the respective field.
4. To choose an appropriate research object and subject.
5. To participate in the preparation of the application for a research project.
6. To form part of an interdisciplinary research group.
7. To choose the most appropriate data and information processing solution.
8. To interpret research results.
9. To prepare a report on research results.
10. To perform the statistical processing of data.
11. To prepare presentations, reviews, and publications on research results in the respective field and professional activity.
12. To adhere to the principles of medical and scientific ethics.
13. To observe the norms of communication culture and professional ethics.
14. To embrace the diversity of opinions.
15. To strengthen the company’s reputation.
16. To manage stress in the social communication process. To collaborate with professional organisations – societies and associations in the field of medical engineering.
17. To use critical and creative thinking.
18. To observe the norms of communication culture and professional and corporate ethics.
19. To correctly formulate tasks for subordinate employees and monitor the execution of tasks. To ensure efficient two-way communication with employees.
20. To inform the employees about innovations in medical engineering.
21. To train the personnel on work with medical devices/ equipment/ systems within the scope of own competence.
22. To inform the employees about innovations in medical engineering.
23. To comply with the requirements of the work procedure rules and internal regulatory enactments.
24. To comply with the obligations and rights of the employee in achieving the common goals of the company’s operation.
25. To identify the potential work environment risks.
26. To organise the workplace in conformity with the labour protection requirements and the impact on health.
27. To comply with the requirements of the laws and regulations on the civil defence, labour protection, and environmental protection.
28. To be environmentally conscious.
29. To use communication and information technology tools and services for the performance of the direct duties and communication.
30. To search for the necessary information. using reliable sources, and critically evaluate the credibility of these sources.
31. To assess the benefits and potential risks of information technology in the acquisition and exchange of information.
32. To comply with the data protection requirements when processing information.
33. To assess own professional experience.
34. To plan the learning needs for career growth.
35. To systematically acquire new knowledge and experience.
36. To keep up with the latest developments in the field of medical engineering.
37. To use evidence-based knowledge in practice.
38. To participate in conferences, exhibitions, and forums in the field of medical engineering.
39. To incorporate medical engineering innovations in own professional activity.
40. To communicate in the official language and at least one foreign language orally and in writing in various professional situations and environments.
41. To use the professional terminology in the official language and in the foreign language.
42. To observe the literary language norms in oral and written communication.

Professional competences
1. Ability to analyse technical documentation, as well as scientific and professional literature. Ability to evaluate the technical parameters, advantages and disadvantages of medical devices/ equipment/ systems available on the market.
2. Ability to formulate the technical task of designing medical devices/ equipment/ systems.
3. Ability to assess and justify the novelty of devices/ equipment/ systems to be designed.
4. Ability to identify the potential risks for the personnel and patient.
5. Ability to analyse the physical principles of the operation of medical devices/ equipment/ systems.
6. Ability to use the mathematical and physical models of physical energy effects on biological tissues and biocompatible materials.
7. Ability to conduct numerical/model experiments to assess the physical energy effects on biological tissues.
8. Ability to develop the concept and detailed structure of medical devices/ equipment/ systems.
9. Ability to use design software for the development of medical devices/ equipment/ systems.
10. Ability to make well-founded choices of the options of structural solutions.
11. Ability to verify the results of engineering calculations.
12. Ability to make well-founded choices of the options of structural solutions.
13. Ability to verify the results of engineering calculations.
14. Ability to assess operator risks associated with the use of medical devices/ equipment/ systems.
15. Ability to assess patient risks associated with the use of medical devices/ equipment/ systems. Ability to ensure the conformity of the structure of medical devices/ equipment/ systems with the laws and regulations and the requirements of standards.
16. Ability to develop technology for manufacturing medical devices/ equipment/ systems.
17. Ability to prepare the necessary computerised numerical control files for the manufacturing of the components of medical devices/ equipment/ systems.
18. Ability to evaluate the prime cost of the manufacturing and operation of medical devices/ equipment/ systems.
19. Ability to provide recommendations on the potential harmful effects of medical devices/ equipment/ systems subject to surveillance on the human body.
20. Ability to formulate requirements for premises intended for the installation/ operation of medical devices/ equipment/ systems subject to surveillance in order to ensure the patient and operator safety.
21. Ability to select, analyse, consolidate, and use the laws and regulations, and standards related to the operation, technical surveillance, and safety of medical devices/ equipment/ systems.
22. Ability to provide recommendations for implementing or enforcing requirements during the acceptance of the medical devices/ equipment/ systems subject to surveillance for operation, as well as during their operation and disposal.
23. Ability to test the functionality of medical devices/ equipment/ systems, identify equipment damages, and rectify them or organise their rectification.
24. Ability to select adequate dosimetric, radiometric, and spectrometric measurement methods and equipment.
25. Ability to assess the measurement uncertainty and analyse the obtained results.
26. Ability to plan quality assurance measures and organise them according to the priorities.
27. Ability to develop a radiation safety quality program.
General competences
1. Ability to prepare the design documentation for the device/ equipment/ system project.
2. Ability to communicate with representatives from other sectors.
3. Ability to conduct applied research and prepare and present publications.
4. Ability to explain the issues of sustainable development and define evidence-based conclusions.
5. Ability to demonstrate personal, social, and civic skills which are essential for active and effective participation in professional activity and creation of a social dialogue.
6. Ability to adhere to the basic principles of professional and general ethics and generally accepted codes of conduct.
7. Ability to manage the work of technical and paramedical personnel.
8. Ability to manage a group of subordinate employees – technicians.
9. Ability to plan the work and organise it according to the priorities.
10. Ability to consult the medical personnel on the operation and technical operational aspects of medical devices/ equipment/ systems.
11. Ability to collaborate with representatives from other sectors.
12. Ability to perform work tasks in conformity with the labour protection, environmental protection, and civil defence requirements specified in laws and regulations.
13. Ability to observe the norms of employment relationship.
14. Ability to draw up business documents by using software to create texts, drawings, and graphics. Ability to safely use information technologies for work and
15. communication, while ensuring the compliance with data protection requirements.
16. Ability to use means for the search and selection of information.
17. Ability to find, select, and analyse scientific and professional literature.
18. Ability to organise own work, constantly evaluate own level of qualification, acquire new knowledge and competences in the professional field, and develop professional and personal skills.
19. Ability to communicate, write, read, work, and speak fluently in the official language and at least one foreign language while understanding and using professional terminology and concepts.
20. Ability to analyse the scientific literature in the official language and foreign language, and use it in practice.