Medical Device Regulatory Affairs Consulting

Lean into our regulatory affairs and compliance know-how.

With the medical device regulatory environment continually evolving, clients depend on our team of experts to provide crucial guidance to expedite time to market.

Failure to comply with regulatory requirements can trigger recalls or delay approvals of new products, resulting in costly mistakes.

We guide clients throughout the product lifecycle, including defining regulatory strategies, developing regulatory submissions, and assessing the regulatory impact of labeling and design changes.

Our team of experts can prepare custom-tailored regulatory documentation that meets your business objectives, including:

  • FDA Presubmission
  • FDA 513(g) Request for Information
  • FDA 510(k) Premarket Notification
  • FDA Premarket Approval (PMA)
  • FDA Investigational Device Exemption (IDE)
  • CE Technical Documentation and Design Dossiers
  • Clinical Evaluation Report (CER)
  • Health Canada Licenses
  • Good Laboratory Practices (GLP) support documentation
  • Other country submissions, as requested

Knowledge Panel

October 5, 2020

Startup Series: A Medical Device Quality Standards Primer

September 1, 2020

Standards Updates: Risk Management for Medical Devices

Have a specific regulatory need not listed above?

Our diverse team is available to discuss and advise.

Looking to quickly expand your organization’s regulatory capabilities? Consider outsourcing some or all of your regulatory affairs and compliance functions.

Set up a discovery call!