Medical Device Compliance: A Practical Perspective

Join Dan Raymond, Founder of Springboard Solutions LLC who will provide a practical perspective of medical device compliance. Prior to establishing SpringboardWebinar-Annoucncement-2 Solutions LLC, Dan was simultaneously responsible for engineering deliverables and regulatory compliance of one of Medical Device Industry’s most complex products (a proton radiation therapy system) in a startup environment. The dual responsibility and related expertise are uncommon, as these two fields frequently face conflicting deliverables that influence each other's outcomes. Topic areas will include: · What does 21 Code of Federal Regulations 820 really mean from a business perspective? · Regulatory process and the need to have a keen awareness of the regulations at both the macro and micro levels, as well as appreciate the built-in feedback loops to maintain patient safety and efficacy. · An approach to breaking down a lot of interwoven parts. · The new regulatory challenges. Chapters 00:00 – Introduction - About the Speaker Daniel Raymond 07:50 – Regulatory Framework 10:03 – Cost of Compliance 12:11 – Challenges of Compliance 26:10 – Suggested Approach 39:54 – What’s New - Regulations 41:50 - What's New - Inspections 43:30 - What's New - Your SOPs 44:11 - Q & A