REGULATORY AFFAIRS & QUALITY ASSURANCE
Experts in medical device classification, regulatory submissions, and route to market evaluations can develop the right regulatory strategy for your product pipeline.
Our services include:
- Medical Device Classification Consulting
- FDA Premarket Applications (PMA)
- FDA Premarket Notifications (510(k))
- FDA 513(g) Consulting for Medical Devices
- FDA Route to Market Evaluations
- FDA Investigational Device Exemptions (IDE)
- CE Marking Consulting for Medical Devices and IVD
- Technical File Preparation for Medical Devices and IVD
- Regulatory Affairs Outsourcing
Corporate compliance with global regulations is of paramount importance in the development and marketing of new products.
Experts providing the following services will assist your organization in maintaining compliance throughout your products life cycles:
- Quality System Audits and Gap Analyses
- Due Diligence Audits to Determine Quality and Regulatory Compliance
- ISO 13485 Quality Management Systems Consulting and Training
- ISO 14971 Risk Management Consulting and Training
- Quality Assurance Outsourcing
- FDA cGMP Quality System Implementation Consulting
- FDA GMP Overview Training
- FDA GMP Quality System Audits