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Our experts come from testing laboratories and manufacturers. They are familiar with the requirements of the notified bodies and know exactly what is needed for a successful approval.
We use existing data and combine different tests where possible. That saves time and money without compromising on quality.
Our more than 100 experts can also help you with other aspects, such as biocompatibility or electrical safety, and ensure that your documentation is consistent and coordinated.
With short response times and efficient processes, we help you bring your devices to market faster, giving you a competitive advantage.
Our testing and documentation fulfill the requirements of all relevant markets, saving
you the need for costly multiple tests.
We focus on the essentials and avoid unnecessary effort – without any compromises regarding conformity.
Lack of clarity regarding regulatory requirements, uncertainty about the scope of testing, and fear of making mistakes when conducting shelf-life tests and validating transportation can lead to costly delays or even product recalls.
Without professional support, you risk not only the market launch of your medical device but also your reputation.
Our team of experts develops customized testing strategies, defines optimal test parameters, and evaluates both material and packaging to plan your shelf-life tests perfectly.
If desired, we can take over the complete project planning and management for validating the shelf life of your medical devices in close cooperation with external laboratories and your team.
Our experts review your documentation to validate the shelf life and identify gaps to ensure compliance with all regulatory requirements.
To ensure consistent and complete documentation, we integrate all relevant aspects, such as biocompatibility, electrical safety, and risk management.
Contact us now to develop the optimal strategy for proving the durability of your medical devices.
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Our expert team helps you create a complete and legally compliant biocompatibility file.
With our support, you receive compliant documentation to prove electrical safety
or electromagnetic compatibility.
We help you quickly pass approvals, audits, and reviews with legally compliant risk management files and safe devices.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops put you on equal footing with experts.
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