QM system recertified according to DIN EN ISO 13485

Since August 2019, velixX GmbH’s quality management system has been certified according to the latest ISO standard for medical technology development – and has now been newly recertified in August 2022.

During the recertification audit, which took place on August 11th and 12th, the QM system of velixX GmbH was again certified as meeting all requirements of the standard.

“Quality management is a matter of course in medical technology – and for us at velixX it was clear that we would also have our quality management system certified,” emphasizes Managing Director Manfred Augstein. “Quality management does not depend on the size of the company – and we are pleased that we have once again been formally certified as working with medical technology-compliant processes.”

There is no conflict between the organization and the management of modern development processes and good quality management. On the contrary. For the customers of velixX GmbH, the QM certificate is further proof of the reliability and the high quality of results of the services offered.

“Our customers rely not only on our know-how and creative approach to problem solving but also on the reliability and high quality of all our services.”

Long awaited. Exciting from start to finish. And already successful!

It has only been a month since MedtecLIVE in Stuttgart, but the first impression after quite an exhausting week has already been confirmed for velixX.

Almost the entire team was on site. All our engineers were directly approachable and accordingly, many in-depth conversations were possibly. What caused astonishment among some of our new contacts is a matter of course for us:

We are a small team in a highly specialized industry and offer very individual and complex services. Direct communication without long detours is crucial for us. Not only in an initial conversation, but throughout the entire development process.

We are delighted with the great interest shown in us and the numerous new contacts we were able to make in Stuttgart. But we are just as happy about the personal reunions with current and former customers and partners.

See you again in Nuremberg for MedtecLIVE 2023!

Video: © NürnbergMesse GmbH – thank you!

Contact

Manfred Augstein
Wildbader Straße 7
68239 Mannheim
+49-621-437 08 001
mail@velixx.com

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