Gilero provides a wide range of testing services for medical and drug delivery devices, from early proof of concept testing all the way through final design verification & validation. Our testing services include test method development and validation along with test protocol development, execution and reporting. Gilero can execute most types of medical device testing in our onsite test labs, including physical, biological, electrical and software 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
Early packaging evaluations
Vacuum Leak Testing
Mechanical performance testing
Tensile & compression testing
Signal integrity testing
Gamma irradiation test management
Power, Voltage, Resistance & Current
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 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 verification testing is complete, results are compiled and added to completed reports that can be used in regulatory submissions.
Accelerated aging, real-time aging & environmental conditioning
ISO 10993 Biocompatibility test management
Package integrity testing
ASTM F88 seal strength testing
ASTM D4169 shipping and distribution test management
IEC 60601-1 medical electrical equipment testing
ISO 80369-7 connector testing
ISO 7886-1 syringe testing
ISO 7864 needle testing
ISO 8536 infusion set testing
ISO 11608 needle-based injection systems testing
ISO 23908 sharps injury protection 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 testing.