we understand that regulatory compliance isn't just a requirement — it's a critical enabler of your MedTech success. Our comprehensive services cover the full regulatory lifecycle, ensuring your product is aligned with national and international standards from the very beginning.
- Classification
- Strategy
- Documentation
- Submission
- Approval
- Monitoring
End-to-End Regulatory Lifecycle Support
We provide comprehensive, step-by-step regulatory support to guide your MedTech innovation from classification to global market compliance.
Classification Strategy
Identify the right regulatory pathway and risk class for your device across global markets (CDSCO, FDA, CE).
Gap Analysis & Roadmap
Assess compliance gaps and build a clear, customized regulatory roadmap.
Technical Documentation
Prepare audit-ready technical files, risk assessments, and submission dossiers.
Submissions & Liaison
Manage regulatory filings and interactions with authorities for smooth approvals.
Market Access
Navigate country-specific requirements for global market entry and expansion.
Continuous Compliance
Stay audit-ready with ongoing updates, vigilance, and documentation maintenance.
90%
Customer satisfaction
25+
Product Certifications
100%
End to End Compliance
Frequently asked questions
Yes, most Class B/C/D devices require a QMS audit or certification for approval in CDSCO, EU, and FDA pathways.
Absolutely. We develop parallel pathways to optimize approval timelines and documentation reuse.
Ideally during design or feasibility stage—compliance starts with the first design decision.