Practical Regulatory Affairs 2020 - US FDA Medical Devices
What you'll learn
- Learn about US regulations for medical devices, and the role of the FDA
- Understand the various regulatory pathways available for medical devices in the US
- Learn how to practically use the various FDA tools and databases to determine the required regulatory route
- Discover how to navigate the FDA website to find more relevant information for specific devices
- No. A basic understanding of medical device regulations e.g. EU MDD or MDR would be useful, but is not necessary.
From the authors of the leading EU Medical Device Regulations course on Udemy, we now present Practical Regulatory Affairs 2020 for US FDA Medical Devices.
The US is one of the worlds leading medical device markets, with a unique regulatory framework. Being able to navigate the US regulatory landscape is a crucial skill for anyone interested in working in regulatory affairs, or anyone looking to bring a device to market in the US. This course focuses on the practical application of regulatory tools and pathways available through the US FDA, using real-world examples and exercises to help you understand not only the regulations themselves, but how to effectively comply with them. Wherever possible, we provide you with relevant links and information from the FDA itself to guide your understanding in each module.
Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and questions we receive from medical device manufacturers looking to enter the US market.
Who this course is for:
- Junior Regulatory Affairs professionals
- Engineers with medical device experience
- Physicians/Professors with device ideas
- Medical device project team members
Medical device and Regulatory Affairs professional currently working in industry. Over eight years of experience in medical devices with expertise in EU, USA and global medical device regulations for a range of device areas including orthopaedics, cardiovascular devices and other active implantable devices. Seasoned trainer delivering courses and educational material to medical device professionals looking to expand their knowledge and skill-sets.