2RA Labs specializes in the testing, validation, and development of medical devices and combination products. With a strong focus on regulatory compliance and international standards, we provide end-to-end support—from performance testing to submission and approval—helping clients accelerate their path to market.
2RA Labs provides GMP audits, regulatory consulting, and EU MDR certification support for medical and pharma manufacturers. We align with global standards (ISO, FDA, EMA) and offer lifecycle services including test method development, DHF consulting, inspection, and complaint management.
+91 90999 60681
End-to-end testing for Pen injectors, Autoinjectors, Pre-fillied Syringes and OBDS devices, ensuring safety, performance, and ISO compliance.
Device performance testing as per ISO 11608 , ISO 11040 & relevent regulatory standards for proven performance.
Testing to ensure correct fit, safety, and consistent, reliable performance of needles with medical devices.
Tailored setups for advanced and precise testing of smart autoinjectors, OBDS, and drug delivery systems.
Comprehensive performance comparisons and insights to select the best suppliers and high-quality components.
Expert GMP audits, specialized training, detailed consultation and regulatory compliance.
End to end support for MDR license application & approvals
Test Method Development & Transfer, DHF Consultation & Support, Incoming Inspection & Lot Release Testing, Complaint Management & Root Cause Investigation support
Open for Testing & Compliance
Book an appointment with our experts to discuss testing, validation, and regulatory needs.
