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 assist in identifying and evaluating suitable locations for establishing medical device or healthcare manufacturing facilities. Our assessment includes considerations of regulatory zoning, infrastructure, utility availability, proximity to logistics hubs, and long-term scalability, ensuring alignment with project goals and statutory compliance.
Navigating local and national regulatory bodies is complex. We manage the entire statutory approval process, including obtaining licenses from bodies such as the Pollution Control Board, Fire Department, Municipal Authorities, and CDSCO, ensuring the facility meets legal and environmental compliance requirements.
Our engineering team develops detailed facility layout drawings using AutoCAD, tailored to ISO 14644 cleanroom standards and GMP requirements. The layout is optimized for material flow, contamination control, utility management, and future expansion, forming the structural blueprint for regulatory submissions and construction.
We design AHU systems critical to cleanroom functionality. Our approach includes defining filtration stages (pre, fine, and HEPA), airflow patterns, differential pressure management, temperature/humidity control, and ducting strategy. Designs meet ISO 14644 and NABL norms for sterile and semi-sterile environments.
We support the construction and commissioning of ISO-classified cleanrooms (ISO 5, 6, 7, and 8) suitable for sterile manufacturing, diagnostics, and packaging. This includes material selection (PUF panels, epoxy flooring), access control, pass boxes, and integration with environmental monitoring systems, adhering to ISO 14644-1 standards.
We design and validate key processes such as sterilization (autoclave, EO, gamma), gowning procedures, and controlled men-material movement workflows to ensure contamination control. Documentation and execution are aligned with GMP and ISO 13485 standards, supporting routine audits and compliance inspections.
We offer consulting for BMS integration to control HVAC, lighting, security, and critical utility systems. BMS integration ensures real-time monitoring, energy efficiency, alarm management, and regulatory documentation. Our expertise spans platforms compliant with 21 CFR Part 11 for audit trail requirements.
We provide turnkey solutions for setting up advanced clinical simulation labs in alignment with National Medical Commission (NMC) guidelines. Our service includes space planning, equipment procurement, installation, and SOP development for skill-based training of medical students.
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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