QMS Compliance
- Gap analysis- [ISO 13485, 21 CFR 820, QMSR]
- QMS Remediation
- Audit Support
- ISO 13485 Certifications
- Computer System Validation
Regulatory Services
For importers and Manufacturers
- Regulatory Strategy for Global Markets. EU-MDR/ US FDA/ UKCA/TGA
- CDSCO – Import, Test & Manufacturing License
- EMI-EMC/Usability/ SDLC
- Biocompatibility Evaluation Plan
- Packaging & Reprocessing Validation
Training
We can train your team on following.
- QMS (ISO 13485)
- Usability Engineering (IEC 62366)
- Risk Management (ISO 14971)
- Design Controls ( 21 CFR 820)
- Software Life cycle processes (IEC 62304)
Medical Writing
- Clinical Evaluation Reports
- Clinical Investigation protocol and Reports
- Post Market Surveillance
- Amendments/updates to dossiers/submissions
- Devleopment of IFUs e.g. User Manual
Authorised representative
in absence of establishment and Local agent in India, Sinnov8 can serve as an authorised agent and can provide you with all the necessary assistance throughout the process of import to launch your product in time.
Labeling and Technical writing
- Labeling intelligence & Global harmonization strategy
- Global UDI compliance
- Country specific labeling compliance
- Labeling Symbology Management
- Technical Writing Services