Regulatory Submissions for Medical Devices

regulatory submission for medical devicesLocated outside Boston, MA, MEDIcept provides expert guidance to help manufacturers navigate the complexities of regulatory submissions for medical devices. Our team understands the critical role that successful submissions play in securing market access and ensuring regulatory compliance. The medical device industry is dynamic, with evolving regulations that can be difficult for manufacturers to manage. MEDIcept’s seasoned consultants specialize in developing tailored regulatory strategies, guiding you through every phase of your device’s lifecycle — from initial development to post-market activities. Our approach not only ensures compliance but also fosters a quality-driven culture within your organization.

Regulatory Submission Support for US and International Companies

MEDIcept supports regulatory submissions for medical devices, covering a broad spectrum of services, including:

U.S.

  • Q-Submissions
    • Pre-Submissions
    • Submission Issue Request (SIR)
    • Study Risk Determination
    • Informational Meeting
  • 513(g) Request For Information
  • Request For Designation (RFD)
  • Pre-RFD
  • Investigational Device Exemption (IDE)
  • 510(k) Submissions
  • De Novo Applications
  • PMA (Premarket Approval Application)
  • Breakthrough Devices Designation (BDD)
  • Safer Technologies Program (STeP)
  • eSTAR Submissions

European Union / EEA

  • EU MDR and EU IVDR Technical Documentation
  • Clinical Evaluation Report (CERs) and Performance Evaluation Report (PERs)

Global Capabilities

  • Due Diligence
  • Labeling Reviews
  • Marketing Material & Social Media Reviews
  • Regulatory Submissions
  • Interim Regulatory Professional (IRP)
  • Person Responsible for Regulatory Compliance (PRRC)

Our team of regulatory experts will help you navigate an optimal regulatory pathway and provide end-to-end support to ensure a smooth submission process.

Tailored Solutions for Every Medical Device Company

At MEDIcept, we recognize that each medical device company is unique. That’s why we customize our regulatory submissions for medical devices to fit your specific needs and objectives. By partnering with us, you gain access to a wealth of resources and expert guidance designed to maximize your potential and keep you competitive in a rapidly changing market.

Take the first step towards streamlined and effective regulatory submissions for medical devices. Contact MEDIcept today to see how our regulatory professionals can support your business with compliance, efficiency, and a commitment to quality.

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