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Regulatory

Are you facing regulatory challenges? We can help.

Commercializing medical devices requires careful navigation through complex and often confusing 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.

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As international regulatory consultants, we have decades of hands-on regulatory strategy and implementation experience, successfully gaining regulatory clearance for numerous types of medical devices.

All medical device manufacturers need a regulatory strategy, and they need it very early in the product development schedule—a defined, clear path to bring the product to market. We have helped start-ups and mature companies identify the device’s classification, the standards required to be met, and the regulatory pathway to success.

In need of assistance with a 510(k), PMA, or de novo? MEDIcept provides expertise for all medical device regulatory pathways for those manufacturers and importers who wish to market their products in the US. Not in the US? MEDIcept can act as the US Agent for your company and provide Registration and Listing help.

For medical device manufacturers looking to sell into the European Union, the challenges have become even greater. Significant revisions to the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) place greater responsibility upon manufacturers and distributors to ensure the quality and safety of the products they sell. Obtaining a CE mark requires the know-how to interpret the MDR and present information specific to each country’s requirements. We have written technical files and clinical evaluation reports for all medical device classes and will help you prepare for your Notified Body meetings and audits.

For all medical device designers and manufacturers, feedback from FDA is valuable. The Pre-Submission (or Q-Submission) process is geared at obtaining that feedback. MEDIcept has vast experience with preparing the requests and conducting these meetings with you or on your behalf.

MEDIcept can also help you navigate the complexities created by our current worldwide COVID-19 pandemic. We have helped many IVD and PPE developers with the FDA’s Emergency Use Authorization process and gaining experience in similar processes in non-US countries—we can help you too!

If you are an international company exporting medical devices into the United States, you must have a designated, authorized US Agent. MEDIcept serves as a US Agent for international companies, answering questions and addressing such issues as US Customs seizures and FDA inspection notifications.

Our regulatory consulting services include:

  • Global Regulatory Strategy Development
  • Submissions
  • International Regulations
  • Classification
  • Clinical needs
  • Regulatory Submissions
  • 501(k) submissions
  • De novo reclassification requests
  • Premarket approval (PMA) submissions
  • 513(g) submissions (requests for classification)
  • Technical Files and Documentation
  • Clinical Evaluation Reports
  • Investigational Device Exemption (IDE)
  • Registrations
  • FDA Establishment Registration
  • FDA Medical Device Listing
  • EU CE Mark
  • UK MHRA
  • Australian Medical Device Applications
  • Brazil ANVISA
  • Canadian Medical Device Listing (MDL)
  • Rest of World (ROW)
  • Regulatory due diligence
  • Interim Regulatory Professionals
  • Customized Training and Education
  • Import Detention
  • Data Protection Regulations
  • Removals and Corrections
  • Labeling / website / marketing collateral review
  • Person Responsible for Regulatory Compliance (PPRC)
  • US Authorized Agent
  • Electronic and Laser Product Reports
  • Adverse Event Reporting
    • Medical Device Reporting (MDR)
    • Vigilance Reporting
    • Mandatory Problem Reports
    • Medical Device Incident Reporting (MDIR)
    • Health Hazard Evaluation (HHE)
    • Health Hazard Assessment (HHA)
    • Competent authority communication

I need help NOW!

Have you received an FDA 483 notice or a warning letter? Are you struggling to meet new EU MDR or EU IVDR regs? We can help you respond quickly and effectively to help prevent a difficult situation from getting worse.

Need FDA or EU MDR/IVDR audit assistance?

Don’t go it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.

Are you a start-up?

We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop an appropriate domestic or global regulatory strategy to help ensure compliance and product approvals.