Strong public policy strategies help MedTech companies influence regulations, shape market entry, and build trust with governments and institutions. We provide expert guidance in policy research, advocacy, and stakeholder engagement to help you stay ahead of regulatory changes and position your business for long-term success.
In the initial phase of prototyping, selecting the right system architecture is crucial. We evaluate the intended use, critical performance parameters, safety requirements, and cost constraints to determine the optimal design architecture. This includes deciding between microcontroller-based systems, microprocessors, FPGAs, or hybrid architectures. We consider future scalability, power consumption, real-time processing needs, and regulatory constraints like IEC 60601 for electrical safety. Our team ensures that the chosen architecture aligns with both the device’s functionality and its clinical application.
Creating a solid foundation for any medical device begins with documenting clear and comprehensive System Requirement Specifications (SRS) and Functional Requirement Specifications (FRS). These documents outline what the system is expected to do (SRS) and how each function will be executed (FRS). At D2R, we use a collaborative process involving clinical, engineering, and regulatory experts to develop traceable and testable requirements. These documents serve as the basis for design verification and validation, ensuring full alignment with ISO 13485, IEC 62304 (for software), and MDR/FDA expectations.
Once requirements are finalized, our hardware team moves into schematic development. This process involves detailed circuit design, power regulation, filtering, signal routing, and protection circuitry. We take care to select medical-grade components and ensure patient safety through isolation barriers, leakage current limits, and fail-safes. We follow industry-standard design rules and review schematics thoroughly for redundancy, compliance, and testability before moving to layout.
In PCB layout, precision and compliance are key. Our design team develops compact and optimized layouts, taking into account electromagnetic compatibility (EMC), signal integrity, thermal management, and regulatory constraints. We adhere to standards such as IPC-A-600 and IEC 60601 to ensure robustness. Careful planning of layer stack-up, controlled impedance lines, and separation of high and low-voltage domains ensures your device meets both performance and safety benchmarks.
D2R provides complete design verification to confirm that the developed prototype meets all specified requirements. This includes electrical testing, firmware/software verification, functional validation, and environmental stress testing. We prepare test protocols, traceability matrices, and verification reports aligned with ISO 13485, IEC 62366, and FDA/CE documentation standards. Design reviews are conducted at multiple stages to identify and mitigate risks early, ensuring that the product is ready for preclinical or clinical evaluation.
Our turnkey services cover the full spectrum of device development, making D2R your one-stop development partner. We manage the entire lifecycle from concept design, prototyping, compliance testing, pilot manufacturing, documentation, and even clinical trial readiness. This approach is ideal for startups or companies without an internal R&D team. Our cross-functional team of engineers, regulatory experts, and designers ensures smooth execution, quicker iterations, and better risk management—all under one roof.
For every prototype, the quality of the printed circuit board is foundational. We support clients in sourcing and manufacturing high-quality bare PCBs (rigid, flex, or rigid-flex) from certified partners. These PCBs are built using RoHS-compliant materials, with specific surface finishes (ENIG, HASL, OSP) suited for medical electronics. We manage the Gerber file preparation, stack-up design, and quality inspection (AOI, electrical testing) to ensure that the board meets all technical specifications and industry standards.
We provide full-service PCB assembly using both Surface Mount Technology (SMT) and Through-Hole techniques. Our assembly lines are designed for medical-grade devices with ESD-safe environments and ISO-certified quality protocols. We support low-to-medium volume production runs, ideal for pilot trials, design verification batches, or clinical validation. With automated placement, reflow ovens, manual assembly capabilities, and post-solder inspection, we ensure reliable, production-grade assemblies.
After assembling the PCB, we initiate the board bring-up process—an essential step to ensure that the board functions as expected. This includes power sequencing, clock verification, peripheral validation, and firmware flashing. We perform debugging using tools like oscilloscopes, logic analyzers, and JTAG interfaces. Any anomalies are rectified in real-time to ensure a fully operational board. We also document the bring-up process and initial performance benchmarks.
Before scaling to a production-grade prototype, we help clients build functional Proof of Concept (PoC) units that demonstrate the core features of the medical device. These units are instrumental in early-stage clinical validation, stakeholder presentations, investor pitches, and grant applications. A typical PoC includes the basic hardware platform, essential sensors, basic firmware, and a rudimentary UI. Despite being minimal, these PoCs are built with regulatory foresight and clinical realism in mind.
Strong public policy strategies help MedTech companies influence regulations, shape market entry, and build trust with governments and institutions. We provide expert guidance in policy research, advocacy, and stakeholder engagement to help you stay ahead of regulatory changes and position your business for long-term success.
We ensure your medical device meets international electrical safety standards such as IEC 60601 – 1 (for general safety) and IEC 61010 (for lab equipment). This includes evaluation of leakage current, dielectric strength, mechanical hazards, and patient/operator protection. Safety testing is critical before clinical trials or regulatory submissions, and D2R helps interpret results and implement design improvements for compliance.
Our EMC/EMI testing ensures your device can operate correctly in real-world environments without causing or being affected by electromagnetic interference. We test to standards like IEC 60601-1-2, checking for emissions, immunity to radiated and conducted disturbances, and electrostatic discharge. This is essential for both active implantables and patient-connected diagnostic equipment.
Devices using RF technologies such as Bluetooth, Zigbee, or proprietary wireless modules undergo RF exposure and spectrum performance testing. We measure parameters like transmit power, occupied bandwidth, spurious emissions, and channel stability to ensure regulatory and functional performance requirements are met under FCC, ETSI, and CDSCO norms.
Wireless coexistence testing evaluates how well your medical device performs in the presence of other wireless devices operating in the same frequency band. This ensures robust performance in environments like ICUs or operation theaters where multiple wireless technologies are used. We follow ANSI C63.27 to validate device resilience.
For certain medical devices in India, compliance with Bureau of Indian Standards (BIS) is mandatory under the Compulsory Registration Scheme (CRS). D2R coordinates end-to-end testing, documentation, and lab selection to help clients obtain BIS registration for electronic and radiological medical equipment.
We assist in IECEE CB Scheme testing to allow international recognition of your product safety tests. The CB certification acts as a foundation for CE marking, BIS, and other regulatory approvals. We ensure your testing meets harmonized IEC standards and help prepare technical files for certification bodies.
Devices marketed in the US must comply with FCC Part 15 or other relevant rules for unintentional and intentional radiators. D2R helps manage pre-testing, documentation, and coordination with FCC-accredited labs. This ensures your wireless-enabled device is cleared for distribution in the US.
For the EU market, we support testing under the Radio Equipment Directive (RED) and applicable ETSI standards. Our team ensures that your device meets spectrum usage, EMC, and health and safety requirements. We guide you through documentation and Notified Body interactions when needed.
We ensure your medical device complies with the Restriction of Hazardous Substances (RoHS) directive. This involves analyzing device components for substances like lead, mercury, cadmium, and brominated flame retardants. D2R assists with material declarations, third-party lab testing, and technical documentation for regulatory audits.
Before scaling to a production-grade prototype, we help clients build functional Proof of Concept (PoC) units that demonstrate the core features of the medical device. These units are instrumental in early-stage clinical validation, stakeholder presentations, investor pitches, and grant applications. A typical PoC includes the basic hardware platform, essential sensors, basic firmware, and a rudimentary UI. Despite being minimal, these PoCs are built with regulatory foresight and clinical realism in mind.
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