Course syllabus for Clinical evidence for medical devices

Course syllabus adopted 2023-06-05 by Head of Programme (or corresponding).

Overview

  • Swedish nameKlinisk evidens för medicintekniska produkter
  • CodeEEN171
  • Credits7.5 Credits
  • OwnerTKMED
  • Education cycleFirst-cycle
  • Main field of studyBiomedical engineering
  • DepartmentMEDICIN (GU)
  • GradingTH - Pass with distinction (5), Pass with credit (4), Pass (3), Fail

Course round 1

  • Teaching language Swedish
  • Application code 73122
  • Maximum participants80
  • Open for exchange studentsNo
  • Only students with the course round in the programme overview.

Credit distribution

0123 Project 2.5 c
Grading: UG		0 c0 c2.5 c0 c0 c0 c
0223 Examination 5 c
Grading: TH		0 c0 c5 c0 c0 c0 c

In programmes

Examiner

Eligibility

General entry requirements for bachelor's level (first cycle)
Applicants enrolled in a programme at Chalmers where the course is included in the study programme are exempted from fulfilling the requirements above.

Specific entry requirements

The same as for the programme that owns the course.
Applicants enrolled in a programme at Chalmers where the course is included in the study programme are exempted from fulfilling the requirements above.

Course specific prerequisites

EEN085 - Medicine for engineers or equivalent is required.

Aim

The purpose of the course is to provide basic skills in being able to design clinical medical device trials based on a product's intended purpose and clinical benefit. The course covers technical documentation, clinical evaluation and clinical trials and includes the essential elements for planning and implementation, including ethical frameworks and the regulatory framework for medical devices. The students should be able to plan their own fictitious trial with suggestions on how requirements in regulations must be complied with and how the trial can be designed. The course shall contribute to increasing the understanding of the interaction of medical device with society and other scientific and professional disciplines and approaches.

Learning outcomes (after completion of the course the student should be able to)

  1. account for what is required to plan, carry out and complete a clinical trial for medical device.
  2. analyse, compare and discuss different forms of clinical trials for medical device regarding design and statistical models.
  3. describe current regulations, standards and guidelines in order to be able to evaluate the various components of a clinical trial for medical device.
  4. reason about the ethical issues that must be taken into account in medical device clinical trials and which are regulated in the Declaration of Helsinki and the EU regulations for medical devices.
  5. explain the legal conditions that regulate clinical trials within medical device.
  6. use relevant databases for medical device trials.
  7. reason about for the risk analysis of a medical device and how that effects the technical documentation and the clinical trial.
  8. reason about how the clinical trial fits into the technical documentation and the clinical evaluation for medical devices.
  9. discuss the concept of clinical evidence, in relation to medical device.
  10. develop the ability to work effectively in a group.

Content

The course contains basic knowledge of how clinical trial are planned, organized and implemented:

Intended purpose and clinical benefit
Technical documentation
The risk analysis of a medical device
Clinical evaluation and post market clinical follow-up
Clinical evidence
Ethical issues and values relevant for clinical trials
EU regulations for medical devices in contrast to selected parts clinical trials in medicine
Clinical trials, planning and implementation:
  • method, setup and design
  • applications
  • responsibility, roles and documents
The purpose of the project work is to report on the basis of a medical device which evidence and clinical data are needed to demonstrate clinical evidence for the product, as well as plan the clinical trial required to collect clinical data for the product.

Organisation

The responsible department is the Institute of Medicine, Sahlgrenska Academy at Gothenburg University.

The teaching is given in the form of lectures as well as seminars and consultations in small groups. More detailed information is given on the course website before the start of the course.

Literature

(uploaded in Canvas)

Regulation (eu) 2017/745 of the European parliament and of the council, of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Clinical investigation of medical devices for human subjects ¿ Good clinical practice (ISO 14155:2020)

Wma declaration of Helsinki ¿ ethical principles for medical research involving human subjects

Additional material can be added later, more information is given on the course website before the start of the course.

Examination including compulsory elements

The course is examined with a written exam at the end of the course. Quiz questions, in connection with lectures are optional, but can give bonus points on the written examination.

The project in examined on submitted report as well as active participation at the final project seminar.

Participation in seminars and group work is compulsory, as well as the introductory lecture in the beginning of the course.

Detailed information about the examination is given on the course website before the start of the course.

The course examiner may assess individual students in other ways than what is stated above if there are special reasons for doing so, for example if a student has a decision from Chalmers on educational support due to disability.