spectrum

Regulatory Support

For medium to large-scale projects, Spectrum Plastics Group 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

 

Medical Certifications

ISO and FDA Registered

Spectrum Plastics Group is certified to ISO 9001, ISO 14001, and ISO 13485.