We offer in-house prototyping and MVP development at our Chennai facility for IoMT devices, wearables, point-of-care diagnostics and mid-size medical devices.
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We implement, audit and support QMS, ISMS, EMS, AI-management frameworks and certification body coordination- ensuring operational readiness and regulatory compliance.
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Navigating statutory licenses and registrations in India can be complex-we streamline it for you. From documentation to ministry submissions, we ensure your business is properly licensed, compliant and ready for operation.
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Our approach ensures your study adheres to ethical, regulatory and scientific standards, bridging prototype to full clinical validation. We support feasibility and pilot clinical studies for medical devices, IVDs and SaMD-building clinical study protocols
Read MoreWe deliver end-to-end support for CDSCO (India), US FDA (510(k), IDE, De Novo, PMA), CE marking under EU MDR/IVDR, TGA Australia, Health Canada, UKCA, SFDA (Saudi Arabia), MDA (Malaysia), HSA (Singapore), COFEPRIS (Mexico), ANVISA (Brazil).
Read MoreWe act as your strategic liaison with policymakers, regulatory bodies and stakeholders in the healthcare & medtech ecosystem. Services include policy research & analysis, government and stakeholder engagement, policy advocacy and positioning, scheme and incentive advisory.
Read MoreWe facilitate single-window systems and approvals across ministries, provide market analysis, demand & supply gap assessment, GTM strategy, entity formation, manufacturing unit setup, reliable sales channel hookups, import and statutory/regulatory approvals, KOL (Key Opinion Leader) connect, organising CMEs, M&A and JV support.
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Evaluate your product idea for regulatory classification & technical feasibility.
Our team maps out the clinical, technical, regulatory timeline & deliverables.
From prototyping and AI model development to QMS setup and documentation.
We deliver your complete solution—ready for audit, submission, or go-live.
