Medical Device Cybersecurity Compliance Roadmap and Risk Assessment

Open Opened on September 8, 2025
Main contact
Oxilight Inc
Canada
CEO
(5)
4
Portals
(1)
Project
180 hours per learner
Learner
Anywhere
Intermediate level

Project scope

Categories
Project management
Skills
cybersecurity compliance regulatory affairs cyber security standards medical device development medical devices cyber security assessment cyber security regulatory compliance risk analysis industry standards
Details

Oxilight Inc is developing a medical device that must adhere to the FDA's cybersecurity guidelines. The project aims to create a comprehensive roadmap for achieving cybersecurity compliance, ensuring the device meets all necessary regulatory standards. This involves understanding the FDA's requirements and translating them into actionable steps that can be implemented by the development team. The project will also focus on identifying potential cybersecurity risks associated with the device and developing strategies to mitigate these risks. By applying classroom knowledge of cybersecurity principles and regulatory compliance, learners will gain practical experience in aligning medical device development with industry standards. The project will be completed by a team of learners specializing in cybersecurity and regulatory affairs, ensuring a focused and cohesive approach.

Deliverables

The project will deliver a detailed cybersecurity compliance roadmap tailored to Oxilight Inc's medical device. This roadmap will outline specific steps and timelines for achieving compliance with FDA guidelines. Additionally, the project will produce a cybersecurity risk assessment document, identifying potential threats and proposing mitigation strategies. These deliverables will provide Oxilight Inc with a clear path to ensuring their medical device meets all necessary cybersecurity standards.

Mentorship
Domain expertise and knowledge

Providing specialized knowledge in the project subject area, with industry context.

Skills, knowledge and expertise

Sharing knowledge in specific technical skills, techniques, methodologies required for the project.

Hands-on support

Direct involvement in project tasks, offering guidance, and demonstrating techniques.

Regular meetings

Scheduled check-ins to discuss progress, address challenges, and provide feedback.

Supported causes

The global challenges this project addresses, aligning with the United Nations Sustainable Development Goals (SDGs). Learn more about all 17 SDGs here.

Good health and well-being

About the company

Company
Canada
2 - 10 employees
Business services, Hospital, health, wellness & medical, Science, Technology

Oxilight is a remote-first MedTech product development company, which aims to improve healthcare by bringing innovative and affordable medical technologies.