Design Verification & Validation (V&V) is a critical step in ensuring the safety, performance, and reliability of Pen injectors, Autoinjectors, Pre-fillied Syringes and on-body delivery systems (OBDS). At 2RA Labs, we conduct comprehensive testing in compliance with ISO 11608, ISO 11040, ISO 13485, FDA guidelines, and EU MDR requirements, giving manufacturers confidence that their devices are ready for regulatory approval and market launch.
Design Verification & Validation (V&V) is the process of confirming that a medical device both meets its design specifications (verification) and performs as intended in real-world use (validation). It ensures safety, compliance, and readiness for regulatory submission.
These devices directly impact patient safety and treatment outcomes. V&V testing ensures that every dose delivered is accurate, reliable, and safe under different environmental and user conditions, reducing the risk of device failures.
Our V&V processes comply with ISO 11608, 11040 series, ISO 13485, FDA Combination Product Guidance, and EU MDR requirements, along with GMP and GLP-aligned processes.
The timeline depends on the device complexity, test scope, and regulatory requirements. On average, V&V programs can take several weeks to a few months. We provide tailored timelines after initial project assessment.
Yes. We prepare detailed validation protocols, reports, and risk-based studies that are suitable for regulatory submissions to agencies like the FDA and EMA.
Absolutely. We work with startups, mid-sized manufacturers, and global pharma leaders, providing scalable solutions and tailored support for each stage of product development.
