Design Controls 101 and Implementation Best Practices

Galen Data Medical Device Innovation Webinar Series Presents:   

Design Controls 101 and Implementation Best Practices  

Description:  For many, Design Controls is still a topic that is as confusing today as it was when the FDA first introduced 21 CFR Part 820.  In addition, it is not uncommon to hear negative conversations regarding Design Control processes, yet Design Controls are not just required by the FDA – they are a necessity to be a prudent product developer. Design controls demonstrate our medical devices are safe, effective, and meet the indications for use. This webinar will dive into what Design Controls are, how to address them, and how they benefit your medical device product development efforts.   

Discussion Topics: 

Requirements for different medical device classes 

Overview and practical application of FDA Design Controls 820.30  

The relationship between risk management and design controls 

Practical applications and tips to assist in documenting design controls   

About our Guest:  Our guest, Laura Court, is a Medical Device “Guru” at Greenlight Guru. For the past year, Laura has helped over 100 companies implement their eQMS including advising on Design Controls best practices. Before coming to Greenlight Guru, Laura spent time in the medical device industry as a product development engineer, managing products through full product lifecycle into post-market support.