SolveDx offers a range of specialized services to help you navigate complex markets and achieve your goals in healthcare and public health.
For companies outside the US, we provide comprehensive support for market entry:
Navigate the complex regulatory landscape with our expert guidance:
Expert assistance in securing government contracts and navigating public procurement:
Expert guidance for obtaining Central Drugs Standard Control Organization (CDSCO) approvals for medical devices in India.
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, ensuring safety, quality, and performance. All medical devices require approval before they can be manufactured, imported, or sold in India.
**Device Classification is Key:** This classification (Class A, B, C, D based on risk) dictates the regulatory pathway. For instance, Software as a Medical Device (SAMD) is classified based on its intended use and impact on patient care, often falling into Class B or higher. Higher-risk devices like Class C require more stringent evaluation.
Find your specific regulatory roadmap with advice tailored to your company type and product. Select the category that best describes you:
Whether your product is a Software as a Medical Device (SAMD Class B or higher), a connected health platform, or an AI-driven diagnostic tool, we guide you through software validation, data privacy (HIPAA-like standards in India), cybersecurity, and specific classifications like MD-3 for import. Ensure your digital health solution meets CDSCO's stringent requirements.
From novel diagnostics to advanced therapies, we help translate your academic breakthroughs into market-ready products. This includes early device classification, navigating MD-15 for testing/certification, developing comprehensive technical documentation (Device Master File), and preparing for clinical trial applications and manufacturing licenses (MD-17).
Equip your portfolio companies (med device, diagnostic, biotech, digital health) with foundational regulatory knowledge. We offer workshops, one-on-one consulting, and strategic planning to integrate regulatory compliance into their development roadmap, from prototype to market launch, ensuring they avoid common pitfalls.
If your specific case doesn't fit neatly into the above categories, or if you require specialized assistance with unique medical devices, IVDs, or complex regulatory challenges (e.g., post-market surveillance, audit preparation, change notifications), our team provides bespoke consultation and hands-on support.