Medical Device Regulatory Compliance
Medical device manufacturers face stringent global regulations. We assist in obtaining regulatory clearances, ensuring compliance with evolving standards across markets.
- Device classification and market entry strategies
- Technical file preparation and risk assessment
- Quality management system (ISO 13485) compliance
- Clinical evaluation and post-market surveillance
- Technical file preparation and risk assessment
- Quality management system (ISO 13485) compliance
- Clinical evaluation and post-market surveillance