regulatory services  
FDA   USDA
 
 
ISO CE
MPC provides a full range of regulatory assistance and support to medical device companies. We can help you develop and implement the most advantageous regulatory strategy for your medical device, and prepare and submit the necessary documents to regulatory agencies to obtain marketing clearance.


 

 

Our consultants have extensive experience in regulatory affairs and an in-depth understanding of FDA, Canadian, and European requirements for marketing medical devices. MPC consultants include former senior regulatory affairs personnel from industry, as well as former senior FDA officials who were responsible for the review and approval of new medical devices.

With the combined experience and technical skills of our consultants, we can assist both large and small companies in bringing their products to market in the most direct, cost-effective manner. We can handle single projects, supplement your existing staff for specific tasks, or provide complete regulatory support for your company.

 

Key Regulatory Services

  • Assess impact of regulatory environmental and FDA policies
  • Design pre-clinical and clinical studies
  • Evaluate technical and clinical data
  • Communicate and meet with FDA
  • Investigational Device Exemption (IDE) applications
  • Pre-market notifications [510(k)s]
  • Pre-market approval (PMA) applications
  • Device reclassification petitions
  • Master files
  • Canadian device license applications
  • Technical files for EU