The medical device space and the FDA landscape (regulatory process) can seem very confusing and overwhelming. There exist requirements that are standard (FDA registration, quality system requirements, etc.) and then there are guidance documents that evolve and change (sometimes quickly and sometimes not) as new information is learned about a specific technology. Additive manufactured medical devices is one of the fastest-growing segments in the orthopedic device and other medical/healthcare space; staying current with the regulations is critical to ongoing success for your company. If you are considering or currently are manufacturing medical devices with AM technologies, this presentation will provide an overview for what it takes to have a regulatory compliant device, including testing (this includes regulatory safety and efficacy testing as well as lot release testing requirements), validations, quality system requirements and best manufacturing process requirements to meet and maintain FDA registration, ISO 13485 compliance and good standing with FDA-cleared devices.
- Understand, at a high level, what is required for a company to be FDA compliant when they are an AM medical device manufacturer.
- Evaluate their company's current quality systems and identify any gaps between current practices and regulatory requirements for AM medical devices.
- Understand the most current regulatory requirements for mechanical testing and bio compatibility testing.