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 Springboard 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.