510K Submission and Regulatory Support

510K Submission & Regulatory Support

For medium to large-scale projects, Xeridiem Medical Devices closely manages the complete approval process for your product. Services are provided for Class II & III medical devices, specializing in minimally invasive procedures. Products are supported for multiple approvals and the satisfaction of regulatory bodies worldwide. Our regulatory and quality consulting services are constructed by a dedicated team and pre-qualified external service providers.

Services provided include:

Regulatory Affairs & Quality Assurance

Regulatory & Clinical Strategy Development

Data Management

Submission Preparation Service

Approval Process Management

Post Approval Services – Field Management

Xeridiem clients have filed more than ninety 510K’s with the FDA, for over 1,000 medical products.


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 Silicone Extrusions

-ISO 10993 & USP Class 6 Silicone Rubbers

-Close tolerance

-Translucent

-Pigmented

-Single lumen

-Multi-lumen

-Co-extrusion

-Profiles, tapes & rods

-Radiopaque

-Cut to length

-Pad printing

-Color Striping