Designing for Compliance (SaMD vs. Physical Devices)

Galen Data Medical Device Innovation Webinar Series Presents:   

DESIGNING FOR COMPLIANCE: QMS AND VALIDATION TESTING FOR SAMD VS. PHYSICAL DEVICES  

Get compliant, stay ahead. If you're involved in building a medical device, you'll definitely want to join our upcoming webinar with Kyle Rose, President of Rook Quality Systems.   

Discover the keys to designing your organization and processes that will ensure maximum success in the future. We'll be discussing testing requirements and best practices for medical device QMS; and comparing the overlap and differences as they relate to SaMD vs. physical devices.   

Learn from industry experts and gain a competitive edge in bringing your product to market. Register now!  

Key Takeaways:  

👉 What testing is required for SaMD products and Hardware products? 

👉 How does that testing change if there is hardware involved with the medical device? 

👉 When should you begin the planning and testing phase for your medical device product? 

👉 What are best practices for documenting your validation results for FDA and ISO review? 

👉 How should you incorporate usability into your validation for SaMD and Hardware devices?  

About our guest: Kyle Rose is a medical device expert specializing in development of efficient Quality Systems for small and startup medical device companies. As President of Rook Quality Systems, Mr. Rose works as a contract Quality Manager for multiple medical device companies, overseeing overall quality strategy, and ensuring compliance through documentation and auditing services. Mr. Rose is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets, including FDA, CE Mark, Health Canada, and CFDA. Mr. Rose encourages the simplification of Quality Systems to reduce the quality burden and improve compliance through training and efficient QS design.