Our Mission
To empower medical device innovators with complete regulatory solutions that enable global market access while prioritizing patient safety and compliance with high regulatory standards.
01
Our Vision
To be the most trusted regulatory consulting partner for medical device manufacturers seeking market approval in India, the United States, and European markets.
02
CDSCO India Regulations
- Understanding of the Indian MDR (Medical Devices Rules, 2017).
- Knowledge across all 12 chapters and 8 schedules.
- Familiarity with over 40 MDR forms and submission requirements.
- Insights into device classification (Class A medical Device, Class B medical Device, Class C medical Device, Class D Medical Device) and essential principles.
USFDA Requirements
- Risk-based classification expertise (Class I, II, III).
- Specialization in 510(k) USFDA, PMA, and FDA De Novo pathways.
- Quality System Regulation (QSR/QMSR) compliance, aligned with ISO 13485.
- eSTAR submission skills.
EU MDR Compliance
- Complete CE Marking process under the EU MDR 2017/745.
- Technical Documentation requirements (Annex II & III), covering GSPR.
- Clinical Evaluation Report (CER) writing.
- Post-Market Surveillance and Vigilance.