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University of Aveiro

Medical Device Development

Practical Information

Commencing Date:
tba
Language:
English
Location:
Aveiro Portugal


Teaching Methodology:
Blended Learning


European Fees:
300 EUR
Scholarship Possibilities:
No

Course Contact

Bruno Gago

(+351) 234 247 247

bmgago@ua.pt


Website

Office Link

University of Aveiro

University Accreditation: Yes

Centre of Excellence

Description

This is a 3-day stand-alone short course. It consists in a series of learning events, namely lectures, seminars, presentations, discussion panels and case studies. Pre-course distance-learning activities will also be available for the interested participants.

Outcomes

On successful completion of this Module the student should be able to: Describe and define the field of medical devices, the distinguishing features of medical device technologies, industries and regulatory framework as compared to medicinal products. Interpret the conformity assessment of medical devices based on essential requirements. Categorise medical device products according to the relevant classification and demarcation principles. Describe and illustrate non-clinical and clinical development of medical devices, standardisation and use of standards: European standards, national standards, ISO/IEC standards and harmonised standards. Quality management. Appraise the vigilance and risk management programmes for medical devices. Interpret the principles underlying the compilation of technical dossier/design dossier. Appraise the combined pharmaceutical, clinical pharmacological and technological requirements for the development of medicine-medical device combinations. Evaluate the need and requirements for the joint development of targeted medicine therapy and the related companion diagnostics. Assess the medical needs and clinical significance of emerging technologies. Estimate the requirements for the Health Technology Assessment of medical devices.

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered