Graduate Certificate in Translational Biomedical Engineering (15 credits)

This page lists courses approved for the program. In cases where students have taken one or more of the required core courses as part of another program, these core courses will be replaced with the equivalent number of credits, at the 500 level or higher, by other appropriate courses selected in consultation with the Program Director.

Required Core Courses (9 credits)

Three courses dealing with issues related specifically to the translation of biomedical engineering advances to clinical and commercial environment:

BMDE 653 Patents in Biomedical Engineering

Learning Outcomes

  1. Differentiate the various forms of intellectual property, including copyright, patents, trademarks, industrial designs and trade secrets.
  2. Understand the patent system, including the process of obtaining and maintaining a patent, in Canada, US, and Europe.
  3. Understand a patent document, with emphasis on patent claims.
  4. Have a preliminary experience in drafting patent applications, with emphasis on biomedical engineering subject matter.
  5. Conduct a prior art research, and understand different prior art databases.
  6. Know basic concepts of patent portfolio management, including the enforcement of a patent, and extraction of value from patents.

Course Outline

Course description:

BMDE 653 Patents in Biomedical Eng. 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 654 Biomedical Regulatory Affairs - Medical Devices

Learning Outcomes

  1. Understand the FDA’s, Europe (CE Marking) and Health Canada’s requirements for medical devices.
  2. Gain insight into the best practices required for timely regulatory clearance and entry of medical devices into USA, Europe and Canada markets.
  3. Appreciate the critical role of quality systems and effective process management in the innovation process.
  4. Understand quality management definitions, concepts, and guidelines.
  5. Understand the requirements of the ISO 13485:2016, ISO 14971:2007, and IEC 62304:2006 standards, and FDA’s Quality System Regulations (21CFR820).

 Course Outline

Course description:

BMDE 654 Biomed Reg Affairs-Med Devices 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 655 Biomedical Clinical Trials – Medical Devices

Learning Outcomes

  1. Understand different types of clinical trials based on their design, stage, and purpose.
  2. Determine how to design a clinical trial based on the unique characteristics of the technology, the targeted patient populations, and the purpose of the trial.
  3. Understand basic statistical principles and methods for clinical trial design, analysis, and reporting.
  4. Understand the importance of good clinical practice, good laboratory practice, and quality systems in pre-clinical and clinical evaluations of medical technologies.
  5. Appreciate the impact business models, reimbursement strategies, sales model on the commercial success and the adoption of medical technologies.

 Course Outline

Course description:

BMDE 655 Biomed Clin Trials-Med Devices 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Complementary Courses (6 Credits)

Students must complete six credits of biomedical engineering graduate course work selected from one or more of the following domains or other appropriate courses at the 500 level or higher approved by the Program Director:

General Biomedical Engineering

BMDE 501 Selected Topics:Biomedical Eng 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Biomedical Signals and Systems

BMDE 502 BME Modelling & Identification 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 503 Biomedical Instrumentation 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 512 Finite-Element Modelling:BME 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 519 Biomedical Signals & Systems 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Medical Imaging

BIEN 530 Imaging & Bio Instrumentation 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 610 Functional Neuroimaging Fusion 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 650 Advanced Medical Imaging 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

MDPH 607 Medical Imaging 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Biomaterials and Tissue Engineering

BIEN 510 Eng'd Nanomtls for Biomed Appl 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 504 Biomaterials & Bioperformance 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 505 Cell and Tissue Engineering 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Biosensors and Devices

BIEN 520 High Throughput Bio Devices 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BIEN 550 Biomolecular Devices 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BIEN 560 Biosensors 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 503 Biomedical Instrumentation 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 508 Intro. to Micro & Nano-Bioeng 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Questions?

If you have questions, please info.bme [at] mcgill.ca (subject: Question%20about%20Certificate%20Program%3A%20Course%20requirements) (contact us via email).

Additional information for graduate students can be found on the GPS website.