97905 - Certification and Quality Assurance of Biomedical Products

Academic Year 2022/2023

  • Teaching Mode: Traditional lectures
  • Campus: Cesena
  • Corso: Second cycle degree programme (LM) in Biomedical Engineering (cod. 9266)

    Also valid for Campus of Bologna
    Second cycle degree programme (LM) in Mechanical Engineering (cod. 5724)

Learning outcomes

The student develops specific knowledge on the certification procedures of medical products in use in the European Union, and to a lesser extent also those in use in the United States, the two main markets for medical products. With respect to the preclinical evaluation, the student acquires notions related to evaluation methods for some classes of medical devices and drugs of common use, both in vitro and on animal models. With respect to clinical evaluation, the student acquires knowledge relating to the design of clinical studies. Finally, the current legislation, the most relevant technical standards, and the quality assurance procedures of the production processes are analysed.

Course contents

- Introduction - biomedical product taxonomy and risk classes

- The regulatory process - ISO9000 and ISO13485

- Risk management: ISO14971

- Biocompatibility of biomaterials

- Modes of failure of orthopaedic devices

- Modes of failure of cardiovascular devices

- Animal experimentation and clinical experimentation

- The European system for medical devices: CE mark

- The new European Regulation for Medical Devices (MDR)

- The US system for medical devices: regulatory path

- The European drug system

- In silico medicine: Regulatory aspects

- model credibility according to VV-40


Recommended book: Theisz, V. Medical Device Regulatory Practices: An International Perspective. Jenny Stanford Publishing, 2015. ISBN-10: 9814669105.

EN ISO 9001:2015. Quality management systems Requirements.

EN ISO 14971:2019 ISO 13485:2016. Medical devices — Quality management systems — Requirements for regulatory purposes.

EN ISO 14971:2019. Medical devices — Application of risk management to medical devices.

Regulation (EU) 2017/745 of the European Parliament and of the council of 5 April 2017 on medical devices. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745.

European Medicines Agency, 2019. From laboratory to patient: the journey of a medicine assessed by EMA. https://www.ema.europa.eu/documents/other/laboratory-patient-journey-centrally-authorised-medicine_en.pdf

FDA, 2020. Overview of Device Regulation. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation.

FDA, 2019. Development & Approval Process | Drugs. https://www.fda.gov/drugs/development-approval-process-drugs.


Teaching methods

The course includes frontal lectures in class (where possible), and a practical group activity. This is organised as a role-playing game: the class is divided into two groups, one that will assume the role of producer, the other that of regulator.

The Producer group will create an imaginary company, complete with a name, logo, and letterhead; it will then develop the core of a Corporate Quality Manual, set up the risk analysis for an imaginary medical device, and finally prepare the dossier for this product to obtain the CE mark.

The Regulator group will create an imaginary regulatory services company, will prepare the request to become a notified body, will prepare a product checklist for the type of device that the Manufacturer intends to submit, will evaluate the dossier submitted by the Manufacturer, and will produce a related Notification.

Assessment methods

Oral exam plus group report.

For the achievement of the educational objectives, participation in the exercises and the effective contribution to the group report (which must be delivered within the deadline) are a necessary condition to take the exam.

During the oral exam specific aspects of the group report may be discussed, of which the candidate must show in-depth knowledge. These questions will contribute to the final grade.

Due to the nature of the course and the topics covered, the frequency of lectures and exercises is strongly recommended.

Teaching tools

Official norms and standards.

Office hours

See the website of Marco Viceconti


Good health and well-being

This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.