Verification is proof that your medical device has been properly developed and manufactured, making it an essential part of the development process of any product. Based on a product specification, we develop your optimal testing strategy which ensures complete test coverage and a proper traceability matrix for tracking the specifications and associated tests.For you as a medical device manufacturer, developing a well-thought-out testing strategy offers significant opportunities and the potential to leverage valuable synergies and save costs. Alignment with clinical affairs is particularly important to precisely define preclinical testing and clinical trials.Get in touch with us! Our verification experts are happy to support you in developing or optimizing your testing strategy.
Our services for the testing strategy of your medical device
- Entwicklung einer Teststrategie auf Grundlage Ihrer Produktspezifikation
- Entwicklung einer vollumfänglichen Testabdeckung
- Rückverfolgung der Nachweise auf die Spezifikationen zum Nachweis der vollständigen Testabdeckung
What can we do for you? The best way to find out is to meet with us for the first time, no strings attached!
The right testing strategy to your advantage: Faster, safer, more flexible!
- You have your test tools and test specifications ready on time.
- The necessary resources for development-related testing are clearly defined.
- We reliably develop automated testing tools for development-supporting tests.
- Through us, you have access to various accredited testing laboratories.
How important is the testing strategy for the verification of your medical device?
A well-designed testing strategy improves the quality of your medical device, minimizes the risk of defects, and ultimately increases customer satisfaction.
A well-thought-out testing strategy is the key to a smooth verification process for your medical device. Do you want to ensure that your tests are efficient, risk-based, and fully documented? We can help you develop the right strategy - tailored to your specific needs and regulatory requirements.
Let’s talk about it! Contact us for an initial, non-binding consultation.
- Efficiency: An optimized testing strategy enables efficient use of available resources and streamlines testing efforts. This means that the time and costs required for verification can be reduced.
- Comprehensive coverage: A carefully planned testing strategy ensures adequate coverage of all relevant aspects of the medical device or system, including its different functionalities, boundary conditions, and potential sources of error. This ensures that all relevant scenarios are tested.
- Risk-based testing: A strong testing strategy considers the risks associated with the product or system and prioritizes testing activities accordingly. In this way, tests can be focused on the areas that pose the highest risk to the patient/user or to third parties.
- Adaptability: A flexible testing strategy allows for adjustments to changes in the development process or customer requirements. This is particularly important in agile development environments, where requirements and priorities can change quickly.
- Traceability and documentation: A structured testing strategy ensures complete traceability of testing activities and documentation of results. This is essential for compliance with regulatory requirements and quality standards, as well as for communication with other team members and stakeholders.
A well-thought-out testing strategy is the key to a smooth verification process for your medical device. Do you want to ensure that your tests are efficient, risk-based, and fully documented? We can help you develop the right strategy - tailored to your specific needs and regulatory requirements.
Let’s talk about it! Contact us for an initial, non-binding consultation.
