Other Testing Services
- ETO (Ethylene Oxide) Sterilization Validation
- Class A, B, C Device Testing
- Blood Bag Testing
- Packaging Testing
- Electromagnetic Compatibility (EMC) Testing
Inspection Services
- Device Safety Inspections
- Regulatory Compliance Audits
- Risk and Safety Assessments
Clinical Research and Trials
Shree Icon Research offers end-to-end clinical service management for medical devices, ensuring compliance with regulatory and safety requirements throughout the development lifecycle. Our services encompass feasibility assessments to post-market surveillance, ensuring that devices comply with global standards such as ISO 14155 and CDSCO guidelines.
- Feasibility and Study Design
- Clinical Trials
- Regulatory Strategy and Submission
- Site and Investigator Management
- Patient Recruitment and Retention
- Data Management and Statistical Analysis
- Medical Writing and Reporting
- Post-Market Surveillance and Compliance
- Patient Safety and Adverse Event Monitoring
- Medical Device Performance Evaluation