Regulatory Affairs

At BMP Group, we understand that you want to successfully launch your products as quickly as possible. Let us help you fulfill your regulatory requirements domestically and globally.

Our consultants excel at creating clean and concise regulatory submissions for regulatory agencies worldwide, including the FDA (US), European Notified Bodies, the Health Protection Branch (Canada), and the Ministry of Health (Japan). Because our Consultants can prepare regulatory submissions correctly the first time, we can reduce the number of deficiency requests from regulatory agencies, thus speeding up the entire approval process.

Our consultants' extensive experience gives them in-depth knowledge on how to effectively communicate with regulatory professionals. This makes the entire regulatory process easier for your organization and employees, and can shorten the time it takes to get product approval.

Regulatory Affairs Services Includes:

  • Pre-market notification [510(k)]
  • Investigational Device Exemptions (IDE)
  • Pre-market Approval (PMA) applications
  • Humanitarian Device Exemptions (HDE)
  • Establishment registration and device listing
  • 30-day notice
  • Medical Device Reporting (MDR) and complaint handling
  • CE marking
  • Vigilance reporting
  • Supplements

Contact BMP Group by email or at (650) 743-2465 to discuss your individual needs.