Regulatory Affairs

Regulatory Affairs

"I would like to express my sincere appreciation to you for all of your expertise and assistance in helping us through the arduous FDA Update process. This was such a very important achievement… and opens all the doors for us in our forthcoming marketing activities. Thank you so much for all your efforts on our behalf."

-Neurosurgeon

With the medical device regulatory environment continually changing, clients depend on our experienced consultants to provide crucial guidance to avoid costly mistakes such as data deficiencies or omissions. Failure to comply with regulatory requirements can trigger recalls or delay the approvals of new products, resulting in a substantial loss of revenue for the company.

Our experienced consultants apply their knowledge and expertise of medical device regulations to help companies navigate the ever-changing regulatory environment.  We provide support throughout the entire product lifecycle, such as defining regulatory pathways, managing regulatory submissions, and assessing the regulatory impact of labeling and design changes.

We prepare regulatory strategies with submissions and registrations for:

  • FDA Presubmission
  • FDA 513(g) Request for Information
  • FDA 510(k) Premarket Notification
  • FDA Premarket approval (PMA)
  • FDA Investigational Device Exemption (IDE)
  • CE Technical Files and Design Dossiers
  • Health Canada Licences
  • Other country submissions, as requested

GLP Studies and QAU

Novel devices require non-clinical animal studies to support the safety and effectiveness of the device. QA Consulting serves as an independent Quality Assurance Unit (QAU) during this process to create protocols and oversee methods, verify the integrity of data collected, and facilitate regulatory clearance.

* If you do not see your specific regulatory need listed above, please call us for a more detailed list of services at 512.328.9404

Learn more about our Regulatory Affairs Services