We are hiring for multiple positions for C/C++ Developers & Regulatory Specialists.
Regulatory and quality services
QMS Compliance
Regulatory Services
Regulatory Services
- Review of QMS Documentation
- Support for Audit compliance for MDSAP & ISO 13485
- Support for country specific QMS requirements
Regulatory Services
Regulatory Services
Regulatory Services
For importers and Manufacturers
- Regulatory Strategy
- Product Compliance
- Licences
- Authorized Agent Services
Training
Regulatory Services
Medical Writing
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
Labeling and Technical writing
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
Labeling and Technical writing
Labeling and Technical writing
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 and Technical writing
Labeling and Technical writing
- Labeling intelligence & Global harmonization strategy
- Global UDI compliance
- Country specific labeling compliance
- Labeling Symbology Management
- Technical Writing Services