RJR Consulting, Inc.
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Medical Devices & IVDs

Medical Devices & IVDs


International development and marketing of medical devices require expert level navigation of the regulations and directives to prevent bottlenecks and to minimize risk.

With decades of experience, and our global partners, we are able to bring to you comprehensive medical device consulting, to help streamline the registration and submission processes to save you time and money.


We offer the following services in the area of Medical Devices & IVDs

Clinical Product Development
  • ​Medical device strategy development
  • Assistance with creation of product development plans
  • Clinical Trial Dossiers
  • Investigational Device Exemption (IDE) Applications
  • Development of clinical and non-clinical trial protocols
  • Medical writing/CSRs

Global Regulatory Affairs Support
  • Training on global regulatory compliance for medical devices
  • Authorized representative/Agent in the United States, Canada, Europeans Union, Latin America, Asia-Pacific, MENA, South Africa
  • Global regulatory intelligence for licensing, registrations, renewals, labeling, and on-going updates
International Regulatory Documentation Submissions
  • FDA 510(k) Submissions
  • Pre-Market Approval (PMA)
  • Ex-US Device/IVD registrations
  • Technical Files & CE Marking
  • License renewals; including registrations & certifications

Quality Assurance, Auditing & Inspections
  • Medical device mock audits
  • Assistance with GMP/ISO 13485 inspections, MDSAP
  • Risk management auditing
  • Evaluation of quality systems and processes
  • Manufacturing related quality support; Process validation, cleaning validation, equipment validation and technology transfer

To veiw our case studies concerning our work with medical Devices & IVDs please click here

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  • Home
  • About
  • Services
    • Pharmaceuticals
    • Medical Devices & IVDs
    • Biologics
    • Combination Products
    • Dietary Supplements
    • Cosmetics
  • Global Presence
  • Contact