Guia docente 2023_24
Escuela de Ingeniería Industrial
Máster Universitario en Ingeniería Biomédica
 Subjects
  Certificación de productos sanitarios e innovación en tecnoloxía médica
   Assessment
  Description Qualification Training and Learning Results
Objective questions exam During the course, a series of objective and short-answer evaluation questionnaires will be carried out on the theoretical topics, either considering all the topics as a whole or individualizing each of them. 20 A1
A2
A3
B10
C12
Essay questions exam At the end of the course there is an examination which includes development questions relating to the theoretical and practical content of the course. 25 A1
A2
A3
B4
B10
C12
Problem and/or exercise solving The problems solved in class, after being checked and corrected, can be collected and supplemented with new ones. All of them will have to be commented on and justified before they are finally handed in. Their understanding, explanation and detailed justification will be assessed. 5 A1
A2
A3
B4
B10
C12
Laboratory practice The practices of the subject will be carried out in consideration of two coherent and and complementary blocks:
First block - Certification:
Students must define and develop the documentary and regulatory process that will allow the certification of a health product previously defined in the classes. Each step of the process must be detailed, defining the implementation of the precise quality system and compliance with current regulations. It will also be possible to review the process of integral management of research, development and innovation (R&D&i) in the health sector.
Second Block - Intellectual and Industrial Protection:
In this block, the students will have to define the process of intellectual and industrial protection, as the case may be, describing and finally writing the protection process related to a medical device, which could be the one used in the first block, preferably, or another one. The objective will be to explain in detail each of the steps of the said protection process, describing and analyzing the different stages followed.
In both blocks, the precision and adequacy of the proposals in relation to the stated objectives, the development of the practical work, the degree of autonomy of the students, as well as the choice and monitoring of compliance with the regulations will be assessed. During the practical work, compulsory periodical deliveries and individual and/or group meetings could be considered.
20 A3
A4
A5
B7
B8
B12
D1
D3
Report of practices, practicum and external practices At the end of the course, a complete technical report of the results obtained during the practical sessions of each block of the subject must be prepared. In this report, which may be joint or divided into each block, the processes carried out in each block of exercises must be described and the technical documentation procedure followed must be highlighted.
Among other aspects, the compliance of the proposal with the regulations, the technical writing, and the clarity of the explanation of the stages to be followed will be assessed. Other aspects that will be taken into consideration are the technical and content-related presentation, the student's participation in class and in the work, the adaptation to the deadlines and the presentation and defence of the solution obtained, which is compulsory.
30 A3
A4
A5
B7
B8
B10
D1
D3
 
Other comments on the Evaluation

The assessment of the subject will include the lecturer's assessment of the student's work, both individual and group, whether face-to-face or remote, weighted as indicated in the Assessment section.

To determine the grade for all the assessment tests, a numerical grading system will be used, with values ranging from 0.0 to 10.0 points, in accordance with current legislation (R.D. 1125/2003, of 5 September, BOE. No. 224, of 18 September). In any case, the subject is considered passed if the grade obtained is at least 5.0 out of 10.

The subject offers two different evaluation modalities in its first evaluation period: continuous evaluation and non-continuous or global evaluation. In the second period, the evaluation is carried out exclusively by means of the corresponding global examination.


Comments for the First Assessment Period / Ordinary Exam Period

The student may follow the above modalities:

Continuous evaluation modality

In this modality, the student will pass the subject if he/she obtains a minimum of five points (5.0) out of 10 without having to take the corresponding ordinary period examination. Each assessment test is worth 10 points. It is necessary to obtain a minimum of 5.0 points out of 10 in each of the assessment tests and in each part or subpart of those tests in order to pass the subject. Students who do not pass the continuous assessment, i.e. who do not pass each and every one of the assessment tests set, will be required to take the corresponding additional tests and, if applicable, to take the second period examination. This is subject to the considerations and clarifications deemed appropriate by the teacher.

Non-continuous or global evaluation modality

At the beginning of the course, enrolled students have a deadline set by the School of Industrial Engineering to explicitly opt out of continuous evaluation. In this case, the enrolled student must inform the professor as soon as this has been requested and confirmed. 

A student who opts out of continuous evaluation in order to pass the subject must take a single final examination on the date set by the School for the first assessment period, covering all the theoretical and practical content of the subject, including short answer questions, long answer questions, problem solving and the development of practical scenarios. Additionally, it will be necessary to demonstrate sufficient applied knowledge of the certification process and the intellectual and industrial protection of medical products, as well as the integral management of R&D&i in the healthcare sector. In order to pass the subject, students must achieve an overall mark of at least 5.0 out of 10 in each of these tests.


Comments for the Second Assessment Period / Extraordinary Exam Period

Students who have not passed the subject in the ordinary period by any of the above modalities will have a second opportunity to pass the subject by taking the second period examination on the date set by the School of Industrial Engineering.

The second period examination will cover all the theoretical and practical content of the subject, including short answer questions, long answer questions, problem solving and the development of practical cases. Additionally, it will be necessary to demonstrate sufficient applied knowledge of the certification process and the intellectual and industrial protection of medical products, as well as the integral management of R&D&i in the healthcare sector. In order to pass the subject, students must achieve an overall mark of at least 5.0 out of 10 in each of these tests.


Ethical Behavior

Students are expected to demonstrate appropriate ethical behaviour. In the event of unethical behaviour (cheating, plagiarism, use of unauthorized electronic devices, etc...) it will be assumed that the student does not meet the necessary requirements to pass the subject. In this case, the overall grade for the current academic year will be a fail (0.0). The use of teaching aids or electronic devices during examinations is not permitted unless specifically authorized. Bringing unauthorized materials or electronic devices into the examination room will be considered grounds for failing the subject for the current academic year and the overall grade will be a fail (0.0).

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