Services
Complete Lifecycle Support for Medical Device Innovation
At D2R, we offer a comprehensive suite of services to support medical device innovators throughout the product lifecycle—from initial concept and feasibility studies to regulatory approval, manufacturing, and ultimately commercialization. Moreover, our multidisciplinary team brings deep expertise in biomedical engineering, clinical validation, quality systems, as well as global regulatory strategy (including FDA, MDR, and ISO 13485). Consequently, we work closely with clients to de-risk development, navigate complex compliance requirements, and accelerate time‑to‑market—ensuring the successful delivery of life‑changing medical technologies to patients with confidence.
Medical Device Prototyping
D2R Global Consulting offers end-to-end support for medical device prototyping, helping innovators transform concepts into tangible, testable products. In collaboration with clients, our in-house team of engineers, biomedical specialists, and industrial designers collaborates closely with clients to develop functional prototypes using advanced tools such as CAD modeling, 3D printing, and CNC machining. Importantly, we take into account user needs, ergonomic factors, and regulatory requirements right from the ideation phase ensuring the prototype is viable for clinical use.
What sets us apart is our focus on design for manufacturability and regulatory alignment from the very beginning. As a result, clients reduce development iterations, save costs, and ensure a faster transition to testing and validation. We specialize in devices for diagnostics, monitoring, and therapeutic applications, and we provide comprehensive documentation required for subsequent regulatory and clinical phases.
From concept to completion, we deliver comprehensive electronics solutions tailored for medical devices. Our team specializes in both reverse engineering existing products and designing innovative devices from the ground up — all while aligning with global regulatory standards.
Our Capabilities Include:
- PCB Design & Development – Precision-engineered layouts optimized for safety and performance
- Firmware Engineering – Embedded software designed for reliability, efficiency, and compliance
- Reverse Engineering – Recreate and upgrade existing or legacy devices with modern features
- BoM (Bill of Materials) Optimization – Streamline components for cost savings and supply chain efficiency
- Prototype to Production – End-to-end development, from concept design to scalable manufacturing
Regulatory-Ready Designs
We build with compliance in mind. All designs follow IEC 60601 standards — the cornerstone for electrical safety and performance in medical devices — ensuring smoother certification processes for both CE marking in Europe and FDA approval in the U.S.
Whether you’re enhancing a product or launching something entirely new, we combine technical innovation with regulatory insight to deliver safe, effective, and market-ready medical electronics.
Medical Device Testing
Our testing services ensure that every medical device is safe, effective, and compliant with international regulations. We perform a wide range of tests including biocompatibility (ISO 10993), mechanical integrity, electrical safety (IEC 60601), software validation, and usability testing. Each test is tailored to the product’s risk class and intended use.
D2R also assists in planning and executing pre-compliance and full compliance tests, including test protocol development, coordination with accredited labs, and gap assessments. Our team reviews test data, helps interpret results, and generates submission-ready reports to support applications to CDSCO, CE, and FDA.
Quality Consulting
We assist medtech companies in establishing and maintaining quality systems in accordance with ISO 13485, US FDA QSR, and EU MDR requirements. Our support spans SOP development, document control, audit preparedness, CAPA systems, and training of internal teams to instill a culture of quality.
Whether you’re setting up a new facility, scaling operations, or preparing for certification, D2R ensures your QMS is robust, compliant, and sustainable. We also help clients conduct internal audits and supplier audits and support remediation for regulatory inspections or certification bodies.
Clinical Study
D2R supports the design and execution of clinical studies tailored specifically for medical devices and diagnostics. Specifically, our services include protocol development, biostatistical planning, IEC submission and approval, site identification, as well as study monitoring. Moreover, we ensure that all activities are ICH‑GCP compliant and aligned with CDSCO, FDA, as well as CE requirements.
We also assist with data analysis and clinical evaluation report writing. Whether it’s a pilot study or pivotal trial, we provide customized clinical strategies that reduce approval timelines and support faster market entry while maintaining data integrity and patient safety.
Regulatory & Public Policy Services
We offer regulatory consulting services that guide clients through the entire product lifecycle—from device classification and regulatory pathway identification to dossier preparation and submission. Our team has experience with Indian (CDSCO/DCGI), European (MDR/IVDR), US (FDA) regulatory systems, and other ROW (Rest of the World) registrations.
Our consulting services include gap assessments, responding to queries from authorities, managing communications during inspections, and coordinating with Notified Bodies or Authorized Representatives. We ensure that every regulatory submission is accurate, complete, and aligned with the latest guidelines.
Complementing our regulatory expertise, we also offer Public Policy services that help innovators navigate the broader policy environment. From policy research and advocacy to engagement with ministries, regulators, and think tanks, we support organizations in aligning their strategy with evolving regulatory reforms, accessing government incentives, and influencing policy discourse across healthcare, digital health, and sustainability sectors.
Facility Development
We help companies plan, design, and establish ISO, WHO and GMP-compliant medical device manufacturing facilities. Our turnkey support includes cleanroom classification (ISO 14644), HVAC design, process validation, layout optimization, equipment qualification, and facility validation.
From concept to commissioning, we ensure that your facility meets both operational efficiency and regulatory compliance. Our experience includes setting up facilities for sterile IVD manufacturing, electronic medical devices, and implantable devices, all within tight timelines and budgets.
Healthcare App Development
At D2R Global Consulting, we offer end-to-end digital health product development that addresses regulatory, clinical, and technical requirements. Our team specializes in building scalable, secure, and compliant healthcare applications for diagnostics, therapeutics, patient monitoring, and clinical workflows. Our development process includes requirement gathering, UI/UX design, coding, backend integration, and deployment on Android, iOS, and other web platforms.
Our apps are developed with regulatory compliance in mind, such as IEC 62304, HIPAA, and GDPR, ensuring data security, interoperability, and real-time performance. Whether it’s a software-based diagnostic tool or a mobile health monitoring solution, we help bring digital innovations to life.
App Integration & Compliance
D2R helps medtech companies integrate their software solutions with healthcare infrastructure such as EHR systems, PACS, and LIS. We use global interoperability standards like HL7, FHIR, and DICOM to ensure seamless data exchange.
We also conduct security audits, implement access controls, and ensure adherence to HIPAA, GDPR, and DPDPA (Digital Personal Data Protection Act), 2023 act of Government of India. Our compliance-first approach ensures your applications achieve market-ready and secure across geographies.
India Market Entry Assistance
We provide strategic and operational support for overseas companies looking to launch medical devices or diagnostics in India. Our services market analysis, strategy formulation, entity formation, setting up medical device or diagnostic manufacturing units, connecting with reliable sales channels, mergers and acquisitions, distribution partner identification and post-market surveillance planning.
Our deep understanding of India’s regulatory landscape and our collaboration with incubators and hospitals allow us to streamline the market entry process. From startups to global companies, we enable faster and compliant access to India’s growing medtech market.
Statutory Compliance
D2R supports ongoing compliance with all mandatory regulations affecting medical devices and healthcare technologies. This includes CDSCO renewals, NPPA price control, AERB and PCPNDT licenses, Legal Metrology, and post-market vigilance reporting.
We maintain a compliance calendar, assist in documentation and submission, and coordinate inspections and audits. Our proactive monitoring of regulatory changes ensures that our clients stay ahead and avoid costly penalties or market disruption.
