Medical device manufacturers use DynaQual for two complementary phases: design-validation environmental testing on the device itself, and distribution-qualification testing on the device's primary and shipping packaging.
On the device side, IEC 60601 mechanical-strength and environmental clauses, IEC 60068 thermal/humidity/vibration/shock methods, and ISO 11607 sterile-barrier integrity all map onto profiles we run regularly. For implantable or hermetic devices, our helium-leak benches give a quantitative seal-integrity number with traceable calibration.
On the packaging side, we run ASTM D4169 and the ISTA schedules — random-vibration transport simulation, free-fall drop, compression, and atmospheric conditioning — to verify a device will arrive at the hospital intact. Engineering-signed reports support 510(k), CE, and PMA submissions.
Applicable test standards
- IEC 60601
- IEC 60068
- ISO 11607
- ASTM D4169
- ISTA 1A / 2A / 3A / 6
Relevant DynaQual services
- Vibration Testing — Sine, random, and combined-environment vibration
- Shock Testing — Classical, pneumatic, and drop shock
- Thermal & Climatic Testing — Wide-temperature soak, cycling, and humidity
- Pressure & Helium Leak Testing — Hyperbaric pressure and helium leak detection
- Package Testing — Engineer-driven package and transportation testing