Medical Device Services Portfolio:
- Medical Device Clinical Investigational Studies
- Feasibility Studies,
- Pilot Studies, PASS Studies
- Clinical Follow-up Performance Studies
- Real-World Evidence Studies
- PMCF Studies
- Regulatory Submissions
- Product Registration
- Import/Export
- Investigational Device Exemption (IDE)
USFDA 510 (k) Submissions:
- De-novo 510 (k) Submissions
- PMA Submissions
- Manufacturing License
- Loan Manufacturing License Approvals
- Medical and Scientific Writing Services
- CER (Clinical Evaluation Report) Writing
- Literature review summaries on Analytes
- PER Performance Evaluation Reports
- PMCF Post-marketing Clinical follow-up plans and reports for Class IIa, IIb, III Devices
- Device Vigilance & PSUR Writing
- Toxicology Reports Writing
- Audits and QMS Services (ISO13485:2016)
EU-MDR and IVDR Consulting Support:
- Artwork & Label Management
- EU PMS FSCA Reporting