Regulatory Affairs

Commercializing medical products requires careful navigation through the complex FDA and international regulations. Many companies fail to realize how challenging and expensive regulatory compliance can get without a thorough and effective regulatory strategy based on a strong understanding of the regulatory process.

If you are an international company exporting medical devices into the United States, you must have a US agent based in the United States to answer FDA and US Customs questions. MEDIcept serves as a US agent for international companies, answering questions and helping address such issues as US Customs seizures and FDA inspection notifications.

It all comes down to nuance and experience. At MEDIcept, we have decades of hands-on regulatory strategy and implementation experience, successfully gaining regulatory clearance for over 125 medical devices. We have firsthand experience working with reviewers because some of our staff were FDA and ISO submission reviewers.

All medical device companies must register with the FDA. If they sell products in the United States, they must list their products. MEDIcept helps companies through the bureaucratic FDA database system.

Obtaining an international CE mark requires the know-how to interpret the MDD and present information specific to each country's requirements. We have written technical files for all classes of medical device and will help you prepare for your Notified Body meetings and audits.

Our services include:

• Regulatory strategies
• Regulatory compliance responses (FDA, ISO)
• Regulatory submissions (PMA, 510(k), IDE, CE, BLA for reagents
  and IVDs)
• Compliance audits (FDA, Canada, MDD, ISO)
• Label and labeling compliance review
• US Agent representation for international companies
• FDA registration and listing
• Clinical evaluation reports