Specialised in Medical Devices, IVDs, and Software as a Medical Device (SaMD).
End-to-end regulatory approval — CDSCO, ICMR, NDHM, NABL. From docs to audits, we ensure full Indian compliance.
Comprehensive USFDA support: regulatory strategy, 510k, PMA, De Novo, IDE submissions and end-to-end compliance.
Expert CE MDR/IVDR support: technical docs, CER, PMS, PMCF, GSPR compliance, UDI labeling, and notified body coordination.
Founded in 2018 (formerly Elite QARA Consulting), at D2R Global Consulting, we specialize in guiding Medical Device & SaMD (Software as a Medical Device), IVD and Biotech companies through complex engineering, regulatory, and certification challenges. With expertise across India, US, EU, and global markets, we provide end-to-end support so you can focus on innovation while we handle compliance.
Combined 30+ years of expertise
in regulatory & compliance.Team of 30+ experts brings deep
domain knowledge.End-to-end solutions: Prototype
→ Certification → Market Entry.Global footprint: India, USA,
Europe, Middle East, Africa, Asia-Pacific.Proven track record with
MedTech startups & Fortune 500s
Projects
Customers
Experts
Approvals
Prototyping support for IoMT, wearables, diagnostics, and monitoring devices with compliance testing and ESDM manufacturing expertise.
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End-to-end quality certification support, developing QMS, achieving ISO standards, global accreditations.
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Complete licenses and registrations support, enabling MedTech firms to legally operate with statutory approvals and compliance certifications.
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Design and manage trials with precision and compliance. We support protocol design, site selection, and data readiness.
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Get expert guidance across global regulatory landscapes. Align FDA, CE, ISO certifications (13485, 27001 and more) — right from day one.
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Policy research, advocacy, stakeholder engagement, and incentive advisory for MedTech businesses - we directly work with government.
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Navigate CDSCO, NDHM, NABH frameworks with confidence. We streamline approvals for your MedTech product launch in India.
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We offer customized, regulatory-aligned solutions across the product lifecycle, including prototyping, quality management system (QMS) consulting, pilot clinical study execution, regulatory strategy and submissions, manufacturing facility setup, digital health integration, information security, and India market entry strategy.
100+ successful MedTech
projects deliveredIntegrated AI, product &
compliance teamsExpertise in SaMD, IVDs, and
digital therapeuticsGlobal audit readiness with
local execution precision
An Indian company specializing in regenerative medicine and therapy sought the prestigious DSIR (Department of Scientific and Industrial Research) ...
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An MSME medical device company sought to establish a 100% Export Oriented Unit (EOU) in India. The company aimed to import, assemble...
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A Software as a Medical Device (SaMD) company developing healthcare applications and web portals required ISO 27001 certification to ensure ...
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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.
“Partnering with D2R on the HealthCube project was an incredible experience. Their expertise in medical device prototyping & regulatory compliance took our idea from concept to a fully functional prototype in a seamless manner.”
Hardware Engineer, HealthCubed
“Our Semen Detection Kit’s successful clinical validation was made possible in large part by D2R Global Consulting. Their team’s proficiency in trial execution enabled us to successfully negotiate intricate regulatory environments and produce accurate outcomes.”
CSO, Human BioGenesis
“Working with D2R Global Consulting for our 510(k) submission was a game-changer. Thanks to their support, we are in the process of applying 510(k) clearance for our ‘Epilepsy detection software’ and are now confident in entering the U.S. market.”
CEO, BioAgile Therapeutics
"D2R Global Consulting’s expertise was crucial in helping us secure the CDSCO import license for our medical device. Their structured approach to strategy, advisory, and team coordination ensured a smooth and hassle-free process. With their support, we have secured an import licence for one of our clients."
CRO, HealthMinds Consulting
"D2R Global Consulting’s expertise was invaluable in setting up our refurbished medical device process. Their guidance on regulatory compliance, facility setup, and documentation made the entire process seamless. Thanks to their support, we are now confidently importing and refurbishing devices while meeting all Indian regulatory requirements."
COO, Bluestar Engineering
"D2R Global Consulting provided end-to-end support in testing our endo-tracheal tube, ensuring compliance with ISO and IEC standards. Their expertise in electrical, biological, and mechanical testing protocols, coupled with detailed reporting and actionable feedback, made the process seamless. Thanks to their efforts, we are now ready to launch a globally compliant device."
CEO, GEMN Reaseach and Development Pvt. Ltd
We support early-stage startups, scale-ups, and enterprise teams working on medical devices, digital health platforms, diagnostics, and AI/ML-enabled healthcare solutions. Whether you're building your first prototype or navigating global regulatory approvals—we've got you covered.
Absolutely. We provide end-to-end support—from concept validation, prototyping, and AI model integration to regulatory filings, clinical trials, and QMS implementation. Our strength lies in bridging engineering, compliance, and market readiness seamlessly.
Yes. We specialize in Indian regulatory strategy, including CDSCO medical device registration, ICMR protocols, NDHM compliance, and EHR integration standards. We ensure your product is both clinically and legally ready for the Indian healthcare market.
