We won't sugarcoat it for you...compliance for medical devices is a hard topic to get started with.
With the right tools, and an understanding of some basic topics though, the mystery of how to maintain compliant operations at your company begins to unravel.
During this talk, Nemedio's CEO, Sabrina Varanelli, will help demystify compliance topics with a "crash course" on important regulatory and quality compliance topics that medical device teams need to work in the industry. This talk is ideal for anyone getting started in the world of compliance, and will provide a firm foundation for navigating the complexities that you will encounter as you work the medical device industry.
After this session, attendees should have a basic understanding of:
- Compliance high level terms and definitions
- How to tell the difference between a medical device and a wellness product
- Types of Regulatory Submission
- Quality System Regulations including document control, design control, risk management, and software