Medical Device testing

Design verification/validation testing (DVT) is an important factor of the Design History File (DHF) as per current regulatory requirements of 21CFR 820.30 for all drug delivery device combination products, i.e. Pen devices, Prefilled Syringes, Auto Injector, Nasal Devices and pMDI etc.
Invitron will provide one stop solution for medical devices and combination products testing ,Design verification and Design Validation as per ISO and ASTM standards.
Evolving regulations are dramatically changing the medical device testing requirements.

Services

Perform Design verification testing as per ISO 11608-1, ISO 11608-2, ISO 11608-3, ISO 11040-4
Perform Design verification testing as per device functionality/performance requirements.
Transport simulation as per ASTM D 4169-16, followed by Design verification testing.
- Prefilled syringes with staked needle/luer lock testing as per ISO 11040-4, 11040-8 & Functional parameters.
- Cartridge testing as per ISO 11608-3.
- Pen device and Auto injectors testing as per ISO 11608-1, 11608-2 & functional parameters.
- Nasal device testing as per ISO 20072 & functional parameters.
- pMDI device testing as per ISO 20072 & functional parameters.
- Any other functional parameters as per costumer specific requirement.

Universal Testing Machine (Zwick Roell – Torsion multi-axis testing system integrated with weighing balance)
Key Features: Automatic operation – No manual intervention
- Integrated weighing balance
- Can perform different modes
- Compression
- Torsion
- Tensile
Reduction of total sample quantity