Testimonials
At D2R Global Consulting, we specialize in medical devices and offer comprehensive support across the product lifecycle. With expertise in CDSCO guidelines, FDA regulations, EU MDR/IVDR, and other international & national standards, we provide precise guidance tailored to medical devices.
From ideation and prototyping to 510(k) submissions and integration with PACS/EHR systems, we leverage the latest tools and methodologies to accelerate your milestones. Whether developing SaMD or ensuring ABDM interoperability, our team ensures compliance and efficiency at every stage.
Let us help you bring innovative, compliant medical devices and softwares to market faster.
Device Prototyping
Mr. Revanth A
Hardware and Firmware Engineer, HealthCubed India, Bangalore
IVD Kit Clinical Study
Dr. Debabrata Mandal
Manufacturing Facility Developmment
Bindu Vineeth
SaMD, Class C
Dr. Geeta Manjunath
India Market Entry Assistance
Mr. Sam
510(k) Clearance
Ms. Divya.C
Combination Medical Device
Ms. Rajshri Ojha
MD-15 Import License
Mr. Raghav
Manufacturing License, Class B
Ms. Geethanjali
Device Testing
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.
Mr. Vajramuni
Refurbished devices regulation
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.
Mr. Bijal Shah
COO, Bluestar Engineering, Mumbai
MD-42 wholesale license
D2R Global Consulting made the process of obtaining our MD-42 wholesale license seamless and efficient. Their expertise in navigating regulatory requirements, preparing the necessary documentation, and liaising with the licensing authority ensured a smooth approval process. Their proactive guidance and professionalism have been invaluable, and we highly recommend their services for anyone seeking regulatory support.
Dr. Vigneswaran
CTO, Sperogenx Biosciences, Bengaluru
ISO 13485 certification
Throughout our company’s ISO 13485 certification procedure, D2R Global Consulting offered outstanding advice. Their knowledge of quality management systems, careful documentation preparation, and useful suggestions made sure that we were in compliance without any problems. We were able to successfully align with international medical device standards thanks to the professionalism and practical assistance of their team.
Dr. Thirupathi Raja
CEO, Elscion Biomedicals, Bengaluru
NABL accreditation (ISO 15189)
We received knowledgeable assistance from D2R Global Consulting during our diagnostic laboratory’s NABL accreditation (ISO 15189) procedure. Their in-depth knowledge of quality management systems, practical assistance with documentation, and unambiguous direction on adhering to managerial and technical specifications were priceless. We successfully obtained our national accreditation with their help, and we are now known for upholding the highest standards in medical testing.
Dr. Srinivas
MD, Medilab, Chikmagalur
ISO 9001 certification
D2R Global Consulting provided us with exceptional guidance and support throughout the ISO 9001 certification process. Their expertise in quality management systems and meticulous approach to documentation and compliance made the entire journey seamless. The team’s practical recommendations and hands-on assistance ensured that we met all requirements efficiently. We highly recommend D2R for their professionalism and in-depth knowledge of certification processes.
Dr. Shubhangini
PI, Premas Lifesciences, New Delhi
GMP compliance
Our mammalian cell culture laboratory’s GMP compliance was made possible in large part by D2R Global Consulting. Their knowledge made sure that we easily complied with regulatory requirements, from establishing the lab infrastructure to aligning our SOPs with GMP standards. Achieving compliance was made possible by their careful attention to paperwork, facility design, and quality management systems. We strongly advise anyone wishing to create and manage GMP-certified facilities to use their services.
Mr. Janardhanan
CEO, Stellixir Biotech, Bengaluru
AI/ML based software development
For the development of our AI/ML-based cancer pathology imaging software, D2R Global Consulting offered thorough regulatory guidance. Their knowledge made sure our product complied with the most recent regulatory frameworks, including risk management, clinical validation, and standards like ISO 13485 and IEC 62304. Their tailored recommendations streamlined the development process, helping us build a robust, compliant solution ready for market entry.
Dr. Parthiban
CEO, Vingyani, Chennai
MDR CE certification (MDD to MDR remediation)
D2R Global Consulting’s expertise was instrumental in helping us transition from MDD to MDR CE certification for our medical device. Their thorough understanding of the new EU Medical Device Regulation (MDR), gap analysis, and remediation strategies ensured a smooth and efficient process. They provided tailored guidance on updating technical documentation, conducting clinical evaluations, and aligning with post-market surveillance requirements. Thanks to their support, we successfully achieved MDR compliance, securing our product’s continued market presence in the EU.
Dr. Rajah
Chairman and MD, Scalene Cybernatics Limited, Bengaluru
IVDR CE certification (IVDD to IVDR remediation)
Our in vitro diagnostic instruments’ move from IVDD to IVDR CE certification was made possible with outstanding assistance from D2R Global Consulting. A smooth remediation process was guaranteed by their thorough understanding of the new IVDR criteria, which include improved clinical evidence, performance reviews, and post-market surveillance. They updated our technical documentation, carried out a comprehensive gap analysis, and helped us comply with the strict IVDR criteria. Their knowledge helped us guarantee our product’s place in the EU market and successfully obtain the CE certificate.
Mr. Kamal Sahani
Founder and MD, CliniMinds, Noida
IND (investigational new drug) Regulatory Strategy
D2R Global Consulting provided expert guidance in crafting a comprehensive IND (Investigational New Drug) regulatory strategy for our drug development program. Their team’s in-depth understanding of regulatory pathways, clinical trial design, and compliance requirements enabled us to create a roadmap tailored to our product’s needs. They guided us through compiling the IND dossier, including protocol design, safety assessments, and CMC (Chemistry, Manufacturing, and Controls) documentation and offered valuable insights on preclinical data requirements, risk mitigation strategies, and the regulatory expectations for future submission and trials. Thanks to their strategic approach, we are now well-prepared to advance our drug development with confidence.
Mr. Asim
CEO, Yenepoya Technology Business Incubator, Mangalore
