Medical Device Regulations
What you'll learn
- Learn how medical devices go from idea to product
- Understand the 510K and PMA submission process for medical devices
- FDA regulatory pathways including 510K, PMA, De Novo, IDE, HDE
- Risk management and quality in device development
- Learn how to research new devices and companies
- Understand medical device career paths and opportunities
Requirements
- No prior knowledge of medical device development is required
- Knowledge of basic business practices and project management will be helpful but is not essential
Description
The medical device industry is growing rapidly, providing great opportunities for innovators, experts and entrepreneurs. This course will provide a detailed overview of the way in which new devices go from concept to product, providing you with a starting point to develop a deep understanding of this complex and fast-moving business space.
We will cover all of the key components of bringing a new device to market, including:
Paths to Market, including the 510K, PMA, HDE and other commonly used pathways
Clinical trials of medical devices, including IDE, submissions, records and reporting
Risk management and quality in device development
During this course we will also cover the publicly available information sources that will enable you to research device companies and understand their value. We will cover medical device databases that allow you to research marketed medical devices. We will cover clinical trial databases that allow you to research planned and ongoing trials of medical devices. Links to these freely available resources will be provided.
This course will be a valuable resource for anyone interested in developing their basic knowledge of the medical device industry. For students and recent graduates in medical device engineering, this course will help you develop a knowledge of the industry and the regulatory steps that companies use to bring new innovations to market. For project managers, this course can help you to learn about this industry and equip you to manage medical device development projects. For professionals working in related fields, this course will provide an overview of the medical device industry.
Who this course is for:
- Aspiring regulatory affairs specialists, project managers, subject matter experts and consultants
- Entrepreneurs planning to bring a new medical device to market and need to know how to get started
- Project managers interested in developing their knowledge of medical device projects
- Graduate or undergraduate students wishing to deepen their knowledge of medical devices
- Recently graduated engineers wishing to pursue a career in medical devices
Instructors
![SequenceCentral - IT Training and Consulting](data:image/svg+xml,%3Csvg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 64 64"%3E%3C/svg%3E){kind=avatar}
- 4.4 Instructor Rating
- 121 Reviews
- 3,744 Students
- 4 Courses
From its inception, Sequence Central has aspired to provide companies and organizations with the knowledge and tools necessary to become successful in a fast paced and constantly evolving environment. Our international team comes from diverse backgrounds with experience in the business, NGO, and governmental sectors. We use this diversity and knowledge to create a unique and innovative curriculum of training and consulting services to fit the needs of any company, organization, or individual.
At Sequence Central, we value our clients and seek to provide them with the highest quality services and comprehensive support. What sets Sequence Central apart from other companies is our passion, our original materials, and our integrated and interactive approach to training and consulting. We follow a rigorous methodology to ensure that outcomes meet and exceed the expectations of our clients.
- 4.3 Instructor Rating
- 118 Reviews
- 3,689 Students
- 3 Courses
I'm an experienced data scientist and cloud security architect. I am experienced in designing, implementing and supporting secure cloud infrastructure to support clinical and research environments. I have successfully completed the recently-created CCSP credential and am excited about helping fellow security professionals find the best path to this certification and an exciting career in cloud security.