Regulatory Environment for Prosthetics in the European Union
Project scope
Categories
Market research Competitive analysis Creative writingSkills
prosthetic devices research electrical socketsThe goal of the project is to create a summary document on the needs and requirements for regulatory approval in the European Union within the field of prosthetics and orthotics.
The outcomes will be:
· Reimbursement pathway for prosthetic sockets in the EU including, but not limited to: codes used for prosthetic sockets in the EU, regional coverage policies and limitations to claims, claim parameters for EU reimbursement (eligibility criteria such as manufacturing, materials, production location), reimbursement timelines.
· Identification of reimbursement codes used for prosthetic sockets
· Identification of required ISO standards that are used for socket manufacturing
· Conduct research using regulatory agencies as sources of information
· Attend any relevant workshops or seminars that inform the regulatory structure for nations within the EU (dependent on student availability and outreach)
· Read provided ISO documents to analyze manufacturing requirements for companies in prosthetics space
· Compile summary document with regulatory pathway strategies and suggestions
· Regular meetings with student to address any questions or concerns
· Access to previous regulatory materials as framework for research
· Advice on research strategies and frameworks
· Flexible timelines for completion of steps and final deliverable
About the company
Vessl is changing the way amputees interact with their prosthetic devices. We are a company born out of Canada's premier medical innovation fellowship at Western University and are proud members of Ontario's and Canada's life sciences ecosystem. We are a newly minted company in the early stages of product development for a self-adjusting prosthetic socket, which creates the interface between the amputee's residual limb and prosthesis. Sydney can fill a room with her optimism and makes sure things run smoothly while applying her skills as an engineer to steer the prototype in the right direction. Oleksiy, the clinical anatomist brings a creative touch to every challenge and finds diamonds in the rough to make sure Vessl stays agile and innovative at every step. We are excited to bring new talent onboard and look forward to meeting student's from across the country that can help us take the next steps.