Safety and EMC test laboratory: Fast, safe and cost-effective to a standard-compliant "test report"
We make sure that the electrical safety and electromagnetic compatibility of your medical devices are proven, so that nothing stands in the way of rapid marketing. Without you having to deal with testing laboratories and pay vast sums of money.
How our virtual test laboratory helps you
In our virtual test laboratory, we help you carry out all type tests for your active medical devices (PEMS, IVD, implants) to prove conformity with standards (e.g. IEC 60601-1, IEC 60601-1-2). We take on all the required tasks for you:
- Define test strategy and write test plans.
- Obtain offers and select test centers or test laboratories.
- Identify risks, check or determine key performance characteristics.
- Evaluate the safety concept and, if necessary, develop suggestions for improvement.
- Take care of communication with these test centers and test laboratories.
- Propose solutions if the product is at risk of failing the tests.
- Check the parts of the technical documentation relevant for the tests for completeness, consistency and correctness. Correct, supplement or create documents (e.g. insulation diagrams or risk management files).
- Support when notified bodies or authorities threaten to refuse approval.
We serve as a "single point of contact" for you and take care of all communication with test laboratories and, if you wish, with notified bodies.
At the end of the process, you will have documentation that you only need to submit to your notified body in order to receive approval.
How you can benefit from the test laboratory
Our test laboratory benefits in several ways:
Low costs
- We make sure that the test laboratory does not carry out unnecessary tests.
- We select the laboratory with the best price-performance ratio for you.
- We find solutions to product problems that are not only safe, but also economically feasible.
Safe and successful tests
- We make sure that the test laboratory does not forget any prescribed tests and tests against the correct standards.
- We argue on an equal footing with laboratories and notified bodies and can refute unjustified objections.
- We ensure that the prerequisites for successful tests, such as sound safety concepts and adequate documentation, are met.
Less work
- We serve as your single point of contact and take care of communication with the laboratory and its queries.
- We take over the planning of the test strategy for you.
- We check, improve, supplement and write the technical documentation.
Safer products, lower risks for patients and companies
- We have decades of experience in risk management and systems engineering and find weak points in system and security architecture.
Fast testing and marketing
- We will select the laboratory that delivers fastest for you.
- We create the test plans that the laboratories can work through directly without further queries.
- If tests are unsuccessful, we support you with directly implementable proposed solutions.
Give us a call, send us an email or fill out the contact form so we can
- understand your task,
- if required, agree a confidentiality agreement,
- prepare a tailor-made offer and
- support you as quickly, competently and cost-effectively as possible.
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