visual resource

Medical Device Regulatory Services Handout

Whether struggling with a submission strategy and execution or dealing with regulatory compliance, RCA stands ready to support your medical device needs. Our consultants have years of experience as regulatory and compliance leaders and can help establish solutions for any challenges that surface. Download the complete list of our medical device regulatory affairs services in this handout.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

Please complete the form to access the visual resource.

*=Required

Medical Device Regulatory Services Handout

Medical Device Regulatory Services Handout

Trust the Experts with all your Regulatory Service Challenges

Whether struggling with a submission strategy and execution or dealing with regulatory compliance, we stand ready to support your medical device needs. Our consultants have years of experience as regulatory and compliance leaders and can help establish solutions for any challenges that surface.

Our services highlighted in the handout include:

  • US FDA Traditional Regulatory Strategy and Submissions, such as PMA and 510(k)
  • Innovative Regulatory Pathways such as De Novo Requests
  • Humanitarian Use Device (HUD) and Device Exemption (HDE)
  • FDA Pre-Submission Meeting preparation and support
  • European Union Technical Files and Class III Design Dossiers
  • Clinical Evaluation Reports
  • Global regulatory strategy and product classification
  • Global registration submissions

Interested in Learning More?

Contact Us