Implementation of the Quality Management System in VIBRAINT Inc.

According to the World Health Organization, one in six people worldwide have a stroke. Two out of three survive, but up to 85% suffer from paralysis and only 5% fully restore. This is one of the reasons why the rehabilitation exercise equipment market reaches $2.2B in 2021, as published in Markets & Markets, REHAB EQUIPMENT MARKET – FORECASTS TO 2021, 2019. However, in this huge market there are almost no tools to help in case of large paralysis. VIBRAINT Inc., an Ontario corporation is developing a rehabilitation robotics device named VIBRAINT RehUp incorporating a brain-computer interface (BCI) and purposed to help paralyzed people in regaining motion. BCI helps the largely paralyzed and also provides opportunities for personalized, including at-home, rehabilitation starting from the 2nd-3rd day after stroke, when it is the most effective. VIBRAINT RehUp was successfully clinically piloted and is now being prepared for industrial manufacturing. Through this Mitacs Business Strategy Internship funding VIBRAINT, with Shaw Quality, the consultant firm that VIBRAINT has hired to help with developing the Quality Management System (QMS), two students from Seneca College’s Pharmaceutical Regulatory Affairs (RA) and Quality Assurance (QA) program, under the supervision of Professor Greg Staios, will work on developing QMS documents describing design, manufacturing and handling processes and risks from templates pre-developed by Shaw Quality, in coordination with VIBRAINT professionals.

Faculty Supervisor:

Greg Staios

Student:

Partner:

VIBRAINT Inc.

Discipline:

Life Sciences

Sector:

Manufacturing

University:

Seneca College of Applied Arts and Technology

Program: