Medical Device Regulatory Consulting

Medical Device Regulatory Consulting: International development and marketing of medical devices is a highly regulated process that requires expert level navigation to prevent bottlenecks and minimize risk.  RJR Consulting, Inc. specializes in providing this advanced regulatory consulting expertise to the Medical Device industry. We have decades of experience in the following areas related to the medical device industry:

Clinical product development

• Medical device strategy development
• Assistance with creation of product development plan
• Development of standard operating procedures
• Development of clinical and non-clinical trial protocols

Global regulatory affairs support

• Review of regulatory literature
• Training on global regulatory compliance for medical devices
• Legal/Authorized representative in the United States, Canada, European Union (EU), Latin America and Southeast Asia
• Clinical Research Organization (CRO) management
• In Vitro Diagnostic device evaluations
• Provide regulatory surveillance updates

International regulatory documentation submissions including but not limited to:

• Pre-Market Notifications
• Pre-Market Approval (PMA) process
• Clinical trial dossiers
• Common Technical Documents (CTD)
• Marketing Authorizations (MA)
• Variations & amendment filings
• License renewals including registrations, certifications and product labeling
• Investigational Device Exemption (IDE) applications
• CE Marking for Medical Devices

Quality Assurance, Auditing & Inspections

• Medical Device mock audits
• Assistance with GMP, GCP & GLP inspections
• ISO compliance auditing
• Risk management auditing
• Evaluation of quality systems and processes
• Establishment of a compliance management system