Regulatory Compliance

We can help streamline all your regulatory challenges, from regulatory strategy to commercialization for all classes of medical devices. We have strong understanding and expertise in the regulatory process and we have the know-how to carefully navigate through complex FDA and international regulations.

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FDA and EU Notified Body

Successful Submissions

Medical Systems Consult is ready to assist you with a 510(k), PMA, or de novo. We provide regulatory submission expertise for all medical device regulatory pathways for US and EU markets, and we can facilitate a US Agent for your company and provide registration help. We have the required regulatory experts to help you successfully obtain a CE Mark by presenting the information specific to each EU country's MDR requirements. We have written technical files, risk management reports and postmarket plans for all medical device classes and we can support your needs to prepare for your Notified Body meetings and audits.

It takes less time to do things right than to explain why you did it wrong.

Our regulatory services

  • Global Regulatory Strategy Development
  • FDA Premarket Notification 510(k) submissions
  • FDA Premarket Approval (PMA) submissions
  • FDA De Novo submissions
  • FDA Pre-Submissions (Q-Submission)
  • FDA and EU Device Classification
  • Technical Files Documentation
  • Investigational Device Exemption (IDE)
  • Device Registrations
  • FDA Medical Device Listing
  • EU CE Mark
  • Australian Medical Device Applications
  • Brazil ANVISA
  • Canadian Medical Device Listing (MDL)
  • Interim Regulatory Professionals
  • Data Protection Regulations
  • Labeling & marketing material review
  • Facilitate US Authorized Agent
  • Adverse Event Reporting
  • Medical Device Reporting (MDR)
  • Vigilance Reporting
  • Health Hazard Evaluation (HHE) and Assessment (HHA)
  • Competent authority communication

Partner Experts

Our international regulatory consultants have decades of hands-on regulatory strategy and implementation experience, and have successfully gained many regulatory clearances for a wide range of Class II and Class III medical devices. All successful medical device programs begin with a clearly defined regulatory strategy, which lays out a clear path to bring the product to the intended markets. We have helped both start-ups and mature companies identify their devices' classification, the applicable state-of-the-art standards required, and the regulatory pathway to success.

Need FDA or EU MDR/IVDR audit assistance?

Our regulatory consultants have deep, firsthand experience with FDA and EU MDR/IVDR audits and can help you minimize business risk.

Are you a start-up?

We have helped numerous start-ups develop solid regulatory strategies to clear FDA and EU MDR regulatory requirements and establish a baseline to continue to build on for future product approvals.

Do you have an emergency?

If you have received an FDA 483 warning letter or your regulatory submission was rejected, our experts can help you respond effectively and avoid further delays to move forward.