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
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.
-ISO 10993 & USP Class 6 Silicone Rubbers
-Profiles, tapes & rods
-Cut to length