Services

Medical Device Prototyping

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.

Quality Certification & Accreditation

We implement, audit and support QMS, ISMS, EMS, AI-management frameworks and certification body coordination- ensuring operational readiness and regulatory compliance.

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.

Pilot Clinical Study

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

Regulatory Consulting

We 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).

Government Affairs

We 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.

India Market Entry

We 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.