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.

Gilero Testing Services

Proof of Concept

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

Metrology

Vacuum Leak Testing

Mechanical performance testing

In-circuit testing

Tensile & compression testing

Signal integrity testing

Gamma irradiation test management

Power, Voltage, Resistance & Current

Environmental Conditioning

Electronic coupling

Verification

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

Validation

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.

Summative human factors studies

IFU Validation

IEC 62366-1 usability testing

Simulated use testing

ANSI/AAMI HE75 human factors engineering

IEC 62304 medical device software validation

Software integration, regression & performance testing

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