Services
New Product Development (NPD)
Quality Management System (QMS) (ISO 13485 QSR & IEC 62304)
Quality Management System (QMS) (ISO 13485 QSR & IEC 62304)
- Design
- Design Control Matrix
- Risk Analysis
- GD&T and Tolerance stack up analysis
- Design Verification/Validation (Protocol/Report)
- Usability Engineering
- Biocompatibility report
- Clinical evaluation report
- Vigilance & Post market surveillance
Quality Management System (QMS) (ISO 13485 QSR & IEC 62304)
Quality Management System (QMS) (ISO 13485 QSR & IEC 62304)
Quality Management System (QMS) (ISO 13485 QSR & IEC 62304)
- Establishing and Implementing Quality Policy
- Regular internal audits, external audits, corrective and preventive actions (CAPA), and management reviews
- Customer Focus and Device Safety
Quality Engineering
Quality Management System (QMS) (ISO 13485 QSR & IEC 62304)
Sustenance Engineering
- Support in launching NPD products,
- Process Verification
- Gage R&R studies & Capability Studies
- Manufacturing Process
- Risk Management Support
- Pre Market Studies
Sustenance Engineering
SaMD(Software as a Medical Device)
Sustenance Engineering
- Product compliance – Design history file management
- Engineering Change Management
- Compliance to design control requirements
- Risk Analysis (RMR and DFMEA)
- Technical documentation & reporting
Regulatory Affairs
SaMD(Software as a Medical Device)
SaMD(Software as a Medical Device)
- EU Submissions & Registrations
- EU MDR, NMPA submissions
- 510 (k) and PMA Submissions
- Regulatory impact analysis
- Regulatory gap assessment and remediation
SaMD(Software as a Medical Device)
SaMD(Software as a Medical Device)
SaMD(Software as a Medical Device)
- Software Quality Planning
- Software Development Process
- Assistance in Software Engineering processes(Risk management, Software Verification and Validation in Compliance to IEC 62304)
- Integrating Usability Engineering Process/Human Factors into Software Development