SERVICES

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 U.S. FDA regulatory strategies, EU MDR transition planning, developing regulatory submissions, and assessing the regulatory impact of labeling and design changes.

Our team of medical device regulatory affairs consultants can prepare custom-tailored regulatory compliance 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)
  • EU MDR Gap Analysis and Implementation
  • CE Technical Documentation and Design Dossiers
  • Clinical Evaluation Report (CER)
  • Health Canada Licenses
  • Good Laboratory Practices (GLP) support documentation
  • Other country submissions, as requested
Learn More About Our Medical Device Expertise

Knowledge Panel

May 27, 2022

Free Live Webinar: How to Survive an FDA Audit

January 4, 2022

FDA Inspection Guidelines and Best Practices: Compliance “Do’s” and “Don’ts”

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!