testing throughout product life-cycles

 Testing is an intrinsic component of the medical device product life-cycle and occurs throughout all of its stages, beginning with new product investigation. Testing may be conducted to demonstrate the effectiveness of a device’s clinical, diagnostic, or therapeutic action for its intended use, to determine the robustness, durability and reliability of a device over the course of its anticipated lifetime, to show that users and patients can safely interact with a device through its user interface and patient connections, and to ascertain that a device is compatible with its operating environment. During product development, informal testing is carried out as each component of a system is designed, while formal testing is conducted in accordance with test plans specified for the design verification and validation. During commercial use testing is performed in the course of periodic device calibration and servicing, or in response to trouble complaints and adverse-effect reports.

DEQPRO Medtech Solutions specifies and performs testing for:
  • Device conformance to performance specifications
  • Pre-clinical and investigational testing
  • Identified hazard criticality studies
  • Device lifetime and MTBF tests
  • Software validation
  • Process validation
  • Regression testing
  • Usability testing
  • Device diagnostic testing
  • Design verification and validation

testing performed:
  • Bench top evaluation
  • Component and system-level parametric tests
  • Transfer function determination
  • Stress testing
  • Thermal cycling
  • HV tolerance / breakdown potential

testing outsourced:
  • EMC (formal)
  • Shock, vibration, humidity
  • IEC60601 product certification