Introduction
Who should attend
Features
Course Coverage
Related Courses
The US Medical Device Regulatory Affairs Course provides in-depth knowledge of medical device regulation, registration, and approval processes in the United States. This advanced certification program covers regulatory requirements, strategic management, and business planning for medical devices.
The Course is to impart knowledge and practical understanding about the Regulation, Registration and approval process in United States. This advanced certification course in Medical Devices also covers medical devices strategic management and planning process. Hence, this course will demonstrate medical devices business skills and concepts. The course provides cased based learning. As a result, it is easy for participants to understand the concepts. Moreover, cutting edge simulations help participants apply the knowledge in interactive real life simulation.
Therefore, US medical device training course provides medical devices submission process for US market. Also at the same time, course provided advanced insight on various pathways for USFDA medical devices approval. Â
In addition, this course challenges students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.
The course can be completed at any place. So, it allows the user to stop and start at their leisure.Â
Moreover, user can access the course at own pace. It allows the user to stop and start at their leisure.Â
Snapshots of the course
- Course Code: RYD-082
- Title of the course: Advanced Certification in US Medical Devices Regulatory Affairs (ACUSMDR)
- Nature of the course: Online distance learning course. Course can be accessed online across anywhere 24×7.
- Duration of the course: 1 month from the date of initiation of the course.
- Eligibility: Graduation in any discipline.
- Certification: Certificate will be provided at the end of the successful completion of the course.Â
This course is ideal for regulatory professionals, quality managers, product developers, and business leaders looking to successfully launch, manage, and expand medical device businesses in the US.
Who should attend?
- This course is ideal for US Medical Devices Professionals.
- In fact, the course suits to those who are seeking to improve their skills in the US medical device regulatory environment.
- Those who are entering into regulatory affairs from other areas within a device company (Pharmacists, Clinical Trials, Marketing and others).
- Anyone wishing to update their knowledge on registration in various across different regulatory bodies.
- Those who are working in Business Development and Strategic Planning department.
- Most importantly, this course suits to medical devices regulatory professionals who are handling US market.
Course Features
This online course utilizes 24×7 interactive learning tools to guide each participant through the steps of US medical device regulation and approval process in detail. The course challenges students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
Important Learning Features:Â
- Online 24×7 access from anywhere. Hence, one can learn at your convenience.
- The course provides timing flexibility. In other words, one can attend the lecture sessions at your own convenient time.
- Interactive E-lectures helps user to understand of the concepts effectively.
- Above all, course provides simulation for real life working. Hence, it helps user to apply the decision making skill in real life scenarios.
Unique Features of Royed Training’s US Medical Device Course
- Self-paced Online Learning – Flexibility to learn at your convenience.
- Simulation-based Training – Hands-on regulatory scenario applications.
- Regulatory & Business Integration – Covering both compliance and commercial strategies.
- Comprehensive Coverage – From regulatory affairs to market access & reimbursement.
Course Coverage Area
Regulatory Compliance & FDA Approval
- Understanding FDA 510(k), PMA, De Novo, and Breakthrough Device Program pathways.
- Compliance with Quality System Regulation (QSR), 21 CFR Part 820, and ISO 13485.
- Navigating UDI (Unique Device Identification), MDR (Medical Device Reporting), and post-market surveillance.
Market Access & Business Expansion
- Strategies for launching medical devices in the US market.
- Understanding reimbursement, pricing strategies, and payer expectations.
- Exploring regulatory pathways for startups and multinational companies.
Risk Management & Compliance Training
- Practical insights into design controls, risk assessment (ISO 14971), and human factors engineering.
- FDA audits, inspections, and handling 483 observations and warning letters.
- Cybersecurity and software validation for digital health and AI-driven medical devices.
Hands-on Learning with Real-world Case Studies
- Simulation-based learning to apply real-life regulatory and quality challenges.
- Case studies on successful and failed FDA submissions.
- Scenario-based learning for regulatory strategies and risk mitigation.
Related Courses
Followings are the few of the similar courses, you may be interested in
- Drug Regulatory Affairs Course >> Click here
- Online Training on CE certification >> Click here
- Medical devices regulatory affairs >> Click here
- Drug, Biologic and Medical Devices Regulatory Affairs Course >> Click here
- USFDA Pharmaceutical and Biopharmaceutical Regulatory Affairs >> Click here
