OUR SERVICES
-
​​​​Design and implementation of Quality Management Systems (QMS)
-
Internal audits and gap assessments
-
Process optimization and documentation
-
Continuous quality improvement strategies
-
Comprehensive product review and assessment
-
Design validation and verification
-
Risk management and mitigation strategies
-
Post-market surveillance and compliance monitoring
-
Strategy development for global market access.
-
Preparation and submission of regulatory documents including 510(k) premarket notifications, PMA applications, De Novo requests, and CE marking applications.
-
Expertise in software-related regulatory challenges, including software as a medical device (SaMD) and software in a medical device (SiMD) classifications.
-
Active engagement, interaction, and negotiation with regulatory agencies across different regions.
-
Constant regulatory intelligence, updates, and training to ensure your products stay compliant amidst evolving regulations.