Testing

Testing

Gilero offers a range of testing services for medical devices and drug delivery systems, from early proof of concept through final verification & validation. Our medical device testing services include test method development and validation along with test protocol development, execution and reporting. Gilero can complete most types of testing in our onsite test labs. Our engineers routinely manage physical, biological, electrical and software testing.

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Proof of Concept Testing

Proof of concept testing, or feasibility testing, is used to demonstrate that critical design features of a developed concept will function as intended. Put simply, feasibility testing attempts to answer the question of “will this idea work?” Testing concepts early on, before significant time and money have been invested into development, helps to mitigate risk during the medical device design process. Building upon early design concepts and engineering evaluations, Gilero can identify and execute the necessary early-stage testing of a medical device concept to prove feasibility.

  • Formative human factors studies
  • Metrology
  • Mechanical performance testing
  • Tensile & compression testing
  • Gamma irradiation test management
  • Environmental conditioning
  • Early packaging evaluations
  • Vacuum leak testing
  • In-circuit testing
  • Signal integrity testing
  • Power, voltage, resistance & current
  • Electronic coupling
Next: Verification

Design Verification Testing

Design verification examines whether or not the device meets all specified requirements, making sure that design outputs are the same as design inputs. Depending on the requirements to be verified, a variety of tests will be used for verification. As part of our medical device testing services, Gilero will develop a Design Verification & Validation (DV&V) plan and create formal test methods and protocols that are specific to each device. Most standard test methods can be executed on demand. If custom test methods are necessary, Gilero can develop and execute those tests as well. Once design verification is complete, results are compiled and added to completed reports that can be used in regulatory submissions.

  • Accelerated aging & real-time aging
  • Package integrity testing
  • ASTM D4169 shipping and distribution test management
  • ISO 80369-7 connector testing
  • ISO 7864 needle testing
  • ISO 11608 needle-based injection systems testing
  • ISO 10993 biocompatibility test management
  • ASTM F88 seal strength testing
  • IEC 60601-1 medical electrical equipment testing
  • ISO 7886-1 syringe testing
  • ISO 8536 infusion set testing
  • ISO 23908 sharps injury protection testing sharps injury protection testing
Next: Validation

Design Validation Testing

Design validation confirms that a device meets all user needs and is consistently functioning as intended. For medical devices, design validation testing (and software validation testing, if applicable) should be conducted throughout the development process. Human factors and usability testing are important parts of design validation, and performing this testing helps to ensure that finished devices will be readily embraced by users once they reach the market. At Gilero, we have a dedicated human factors team and on-site human factors observation suite to help us execute this type of design validation testing.

  • Summative human factors studies
  • IEC 62366-1 usability testing
  • IFU validation
  • Simulated use testing
  • IEC 62304 medical device software validation
  • Software integration, regression & performance testing

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