FROM ONE HAND
In the complex world of medical technology, we are a reliable partner for our B2B customers. From data processing and development support to the provision of the documents required for product approvals - we are here for you. Our high-quality processes, including validation, ensure quality and compliance. Thanks to our excellent team, the entire process is not only fast, but also friendly and smooth.
Our strength: We listen, understand and meet the specific needs of our customers.
Leading the way: We discover, develop and take new, unprecedented paths.
The focus is on patient safety and thus the quality of our products and processes.
Promised: We invest in partnership and sustainable cooperation with customers, suppliers and employees.
Short time-to-market for the products thanks to efficient processes in data processing and customer service saves our customers money and nerves and ensures joint success.
You deliver whatever you have as input – drawing, specification, sample or mere idea.
Together with you, we optimize the design from a production, safety and quality point of view.
Production drawings, work instructions, test plans, risk analyses, validations.
Transfer to series production.
Transfer of the Device Master File in the form requested by you or your Notified Body.
From instrument sets to individual handles: only the original Weber Softgrip silicone grips offer maximum patient safety. Thanks to our special process, stainless steel and silicone are bonded in such a way that no gap forms even after hundreds of processing cycles. In this way, the instruments remain cleanable and biologically safe.
We deliver each instrument with documentation necessary for MDR/FDA approval and share cleaning validations, test results on biocompatibility and research on material ageing.
Thanks to Qsistant’s automated information retrieval we can compile the documents with the push of a button – adapted to the needs of our customers.
Visit Qsistant’s website to learn more: