Checking date: 07/05/2025 09:25:29


Course: 2025/2026

Process management and optimization
(20078)
Master in Biomechanical Engineering and Medical Devices (Plan: 545 - Estudio: 409)
EPI


Coordinating teacher: RIOS MUÑOZ, GONZALO RICARDO

Department assigned to the subject: Bioengineering Department

Type: Compulsory
ECTS Credits: 3.0 ECTS

Course:
Semester:




Requirements (Subjects that are assumed to be known)
Courses corresponding to the fields of Biomedical Engineering, Mechanical Engineering, or Industrial Engineering.
Objectives
Upon successful completion of this course, students will be able to: - Understand the stages of design and development of biomechanical and medical devices, including the ethical, legal, and regulatory framework - Understand the concepts of technology transfer - Identify needs and innovative responses to challenges in the field of biomechanics - Design and implement the development stages of biomechanical and medical devices, from conceptualization to commercialization, taking into account regulatory, legal, and ethical principles - Develop and present business ideas
Learning Outcomes
Description of contents: programme
1. Design and Process Development 2. Quality Control and Regulations 3. Risk Management 4. Manufacturing and Production 5. Commercialization and Post-Market Activities 6. Ethics and Social Responsibility
Learning activities and methodology
The course will include theoretical classes in which the instructor will present the fundamental concepts of the subject, encouraging critical understanding through examples and detailed explanations. These sessions will be complemented by practical and theoretical-practical classes, where students will apply the acquired knowledge through exercises, activities, and the resolution of real or simulated cases. Throughout the semester, midterm exams will be conducted to continuously assess student progress, along with a final exam covering the full scope of the course content. Learning will be further reinforced through individual assignments, where students will explore specific topics in depth, and group projects, designed to foster transversal skills such as communication, collaboration, and joint problem-solving. A personalized tutoring schedule will be made available through Aula Global, allowing students to resolve any questions and receive guidance on course content and assignment development.
Assessment System
  • % end-of-term-examination 30
  • % of continuous assessment (assigments, laboratory, practicals...) 70




Basic Bibliography
  • . Real Decreto 192/2023, de 21 de marzo, por el que se regulan los productos sanitarios.. Agencia Estatal Boletín Oficial del Estado (BOE).
  • . Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. European Union.
  • . UNE-EN ISO 13485:2018 Productos sanitarios. Sistemas de gestión de la calidad. Requisitos para fines reglamentarios.. Organismo de Normalización en España.
  • . UNE-EN ISO 14971:2020 Dispositivos médicos/productos sanitarios (MD). Aplicación de la gestión de riesgos a los MD. . Organismo de Normalización en España.

The course syllabus may change due academic events or other reasons.


More information: https://www.uc3m.es/master/ingenieria-biomecanica-dispositivos-medicos