Regulatory Approval for Software as a Medical Device (SaMD)

PROBLEM STATEMENT

An Indian healthcare technology start-up developed a diagnostic Software as a Medical Device (SaMD) for wound care imaging application and required CDSCO approval to launch the product in India. With complex regulatory standards, they needed professional support to manage documentation, navigate the application process, and meet inspection requirements.

Our Approach

Documentation and Submission: D2R Global Consulting took charge of the regulatory documentation from start to finish, ensuring all materials met CDSCO’s rigorous requirements. Our team meticulously prepared the application, aligning every detail with CDSCO standards for SaMD products.
Inspection Process Assistance: D2R provided hands-on guidance throughout the CDSCO inspection. We conducted pre-inspection assessments to ensure readiness, supported the client during the inspection, and addressed any follow-up queries from the regulatory body.

Outcome

The SaMD product successfully achieved CDSCO approval, allowing the start-up to enter the Indian market with confidence. With D2R’s structured approach and regulatory expertise, the client navigated the approval process efficiently and is now positioned to deliver their diagnostic software to healthcare providers across India.

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Regulatory Approval for Software as a Medical Device (SaMD) – Diagnostic Application

PROBLEM STATEMENT

Our Approach

Outcome

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