Learning outcomes

Bachelor’s degree in biomedical, medicine, pharmacist, biology or biochemistry.

Co-requirement : MSBM M102 Preclinical Drug Development MSBM M108 Quality Assurance: GMP, GCP, GLP And Regulatory Aspects SADR M201 Intellectual Property, Patents and Certification MSBM M105 Laboratory research training MSBM M103 Clinical Trials

Goals

Give tools to students helping them to develop, validate and certify innovative medical product, with a focus on bioengineering and Medical Device

Content

The lesson is divided as following:

  • Introduction to bioengineering and definition of Medical Device compared to drugs, cosmetic and parallel products. General frame of regulation and interaction with other product (IVD, ATMP, Drugs, ...) are presented and compared
  • Specifications compatible with Innovation : how to define clearly the specifications of a product without altering innovation. Several tools are proposed and functional specifications is deeply investigated. Collective practices are made on cases.
  • Solution and Innovation: methods and practices to find solutions and manage innovation
  • Development of new product: method to manage the development of new devices. Application to Medical Device and bioengineering
  • Validation and certification: classification of Medical Device, validation through standards and guidelines. Steps for CE marking of Medical Device and overview of IVD and ATMP
  • Reimbursement: overview on reimbursement of Medical Devices in Belgium
  • Perspectives, tendencies and incoming innovation

 

Table of contents

see Content

Exercices

During lecture : individual and collective excercices. Company visit and machine testing (if suitable)

Assessment method

Oral assessment. 2 main questions prepared, and 2 non-prepared sub-questions by main question.

The exact modalities of the evaluation are likely to be modified during the preparation of the examination schedules, depending on the practical constraints with which the faculty administration may be confronted, or in the event of illness / force majeure / encroachment with an internship, or because of the health situation related to the coronavirus.

Sources, references and any support material

ISO standards on medical devices and other medical products, European directive and regulations, specific books (e.g. Risk analysis and specification, …), authorities website (INAMI, MEDDEV, AFMPS, …), open movies, pictures and animations, industrial experience and real cases examples

Language of instruction

Français