The users of medical products and services depend on product availability, performance, and reliability. This requires great attention to the quality assurance activities during the development, manufacturing, and maintenance of these products. We aim for effective and efficient measurement of product and process performance by executing world-class Test & Verification Engineering
Producing and testing a number of samples at this stage helps give us more information about product performance, the manufacturing processes and steps likely to be required.
Test data is reviewed to ensure that the required performance is achieved. Successful completion of the EVT stage enables us to release the product to manufacture in agreement with the customer.
Three main expertise areas of Test & Verification Engineering:
Requirement Engineering as part of Test Engineering: making sure that the product is designed and manufactured right.
Requirement Engineering as part of Test Engineering is the creative, often iterative, process of analyzing and developing requirements and specifications that are needed to verify whether the performance or manufacturing of a device is within the given limits when operated under the allowed use profiles.
In order to establish a test method, requirements or specifications of the product and the operating conditions must be defined in measurable parameters. An appropriate requirements engineering process shall ensure this input.
In the Test Engineering field, there are many different types of Requirements and Specifications, where a Requirement is generally defined as a “Function” the device shall provide and a Specification is defined as a “Design Output” that needs to be verified.
Test Engineering is the creative, often iterative, process of developing test methods, test equipment and test tools, that are needed to verify whether the performance of a device is within the given specification limits when operated under the allowed use profiles.
In order to establish a test method, requirements or specifications of the product and the operating conditions must be defined in measurable parameters. An appropriate Requirement Engineering process shall ensure this input.
Being a health technology company, our products must comply with applicable regulations, often requiring a structured approach to and documented evidence of the products efficacy and safety. For Test & Verification Engineering, this entails a substantiated selection of what and how to test, the justification of test methods, the qualification of the test equipment, the validation of the applied test method, a managed test execution and traceability of the test evidence.
In order to produce reliable test results, the applied test equipment must be capable of conditioning the device and measuring the parameters of interest accurately and precise. Test equipment must, therefore, be designed to ensure this.
Test equipment realization is the process of turning test- and alignment methods into a physical tool. This tool must not only be able to handle, actuate and measure the unit under test, but it must also integrate well into the target environment physically as well as operationally.
In that respect, test equipment must be defined and designed to:
- Load or unload devices under test, manually or automatically
- Manipulate, handle and condition devices under test, preparing them to be measured
- Accurately measure the performance of interest, return the result and report the pass/fail decision
- When needed, combine measurement with adjusting the device under test in order to bring it within specification
- Meet the environmental conditions and footprints of the location where it is to be installed
- Handshake with the MES/ERP systems in order to manage the manufacturing or test flow, order fulfillment, logistical flow, data logging or storage, result reporting, SPC etc.
- Interact with the operator regarding test progress, status updates, test results, operating instruction, feedback of actions etc.
- Provide operator authorization and authentication features for regulatory and security
How Test & Verification Engineering helps to improve product quality?
The four main quality areas are design, internal, supplier and external quality. The test process has a similar approach for each of the indicated areas, but the in- and outputs, purposes and management requirements depend on the area of engagement. Our key focus areas are design quality and internal quality.
Design quality: the product design quality is ensured by verifying if the product achieves the specified performance under the applicable conditions.
Internal quality: the internal quality is ensured by testing during the manufacturing process based on the overall control plan.
Supplier quality: the quality of supplied products is ensured by functional and structural testing. The supplier determines the structural testing and the functional testing is defined by the design team which can be either the supplier or the customer.
External quality: to ensure maximum up-time of the equipment, a test- and diagnostics strategy for fast and efficient repair must be in place.