From Prototyping to Post Approval Change

MedTech AI to

Regulatory Experts

Specialized in Medical Device, IVD & Software as a Medical Device (SaMD)

About Us

CDSCO India

End-to-end regulatory approval — CDSCO, ICMR, NDHM, NABL. From docs to audits, we ensure full Indian compliance.

USFDA

Comprehensive USFDA support: regulatory strategy, 510k, PMA, De Novo, IDE submissions and end-to-end compliance.

CE (EU MDR & IVDR)

Expert CE MDR/IVDR support: technical docs, CER, PMS, PMCF, GSPR compliance, UDI labeling, and notified body coordination.

About D2R Global Consulting

Your trusted partner for regulatory compliance & Growth

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

350

Projects

200+

Customers

30

Experts

125

Approvals

Our Services

Medical Device Prototyping

Prototyping support for IoMT, wearables, diagnostics, and monitoring devices with compliance testing and ESDM manufacturing expertise.

Quality Certification & Accreditation

End-to-end quality certification support, developing QMS, achieving ISO standards, global accreditations.

Licenses & Registrations

Complete licenses and registrations support, enabling MedTech firms to legally operate with statutory approvals and compliance certifications.

Pilot Clinical Study

Design and manage trials with precision and compliance. We support protocol design, site selection, and data readiness.

Regulatory Consulting

Get expert guidance across global regulatory landscapes. Align FDA, CE, ISO 13485, and more — right from day one.

Government Affairs

Policy research, advocacy, stakeholder engagement, and incentive advisory for MedTech businesses - we directly work with government.

India Market Entry

Navigate CDSCO, NDHM, NABH frameworks with confidence. We streamline approvals for your MedTech product launch in India.

Medical Device Prototype

Prototyping support for IoMT, wearables, diagnostics, and monitoring devices with compliance testing and ESDM manufacturing expertise.

Quality Certification & Accreditation

End-to-end quality certification support, developing QMS, achieving ISO standards, global accreditations.

Licenses & Registrations

Complete licenses and registrations support, enabling MedTech firms to legally operate with statutory approvals and compliance certifications.

Pilot Clinical Study

Design and manage trials with precision and compliance. We support protocol design, site selection, and data readiness.

Regulatory Consulting

Get expert guidance across global regulatory landscapes. Align FDA, CE, ISO 13485, and more — right from day one.

Government Affairs

Policy research, advocacy, stakeholder engagement, and incentive advisory for MedTech businesses.

India Market Entry

Navigate CDSCO, NDHM, NABH frameworks with confidence. We streamline approvals for your MedTech product launch in India.

WHY CHOOSE US

We understand the cross functional subject matters better than the conventional consulting

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 delivered
Integrated AI, product & compliance teams

Expertise in SaMD, IVDs, and digital therapeutics
Global audit readiness with local execution precision

CASE STUDY

Our Work

VIEW ALL

DSIR Certification for a Regenerative Medicine

An Indian company specializing in regenerative medicine and therapy sought the prestigious DSIR (Department of Scientific and Industrial Research) ...

EOU Registration for MSME Medical Device Company

An MSME medical device company sought to establish a 100% Export Oriented Unit (EOU) in India. The company aimed to import, assemble...

ISO 27001 Implementation for SaMD Company

A Software as a Medical Device (SaMD) company developing healthcare applications and web portals required ISO 27001 certification to ensure ...

WORK PROCESS

How To Work It!

Pro-Bono Technical & Regulatory Assesment

Evaluate your product idea for regulatory classification & technical feasibility.

Detailed Project Scoping & Roadmap

Our team maps out the clinical, technical, regulatory timeline & deliverables.

Execution & Compliance Milestones

From prototyping and AI model development to QMS setup and documentation.

Final Delivery & Market Launch Support

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. "

Mr. Revanth A

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."

Dr. Debabrata Mandal

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."

Ms. Divya C

CEO, BioAgile Therapeutics

View ALL Testimonials

Our Customers

FAQ'S

Know more about our unique services & process

What types of MedTech companies do you work with?

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.

Can you help us with both product development and regulatory approvals?

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.

Do you offer services tailored for India-specific compliance like CDSCO and NDHM?

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.

NEWS & ARTICLES

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05 Aug, 2025 0 Comments

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