Navigate the audit quickly and safely with a lean QM system


Most companies find quality system audits and inspections stressful. Our quality experts and lead auditors help you with the following challenges:

  • Passing audits and inspections 
  • Getting your tailor-made quality system set up 
  • Streamlining your existing quality system so you can work productively again 
  • Operating your quality system on a permanent basis to avoid audit / inspection stress and enjoy success in the market with your products in the planned time with the intended level of quality

With our help, you can achieve process quality, market and audit / inspection success.

How we help you



What our customers say

"With practical help from Professor Johner and his team, we managed to develop a ‘liveable’ QMS for our company and successfully certified it according to ISO 13485. We really appreciate the pleasant collaboration and the fact that we managed to get our project done in time and at estimated cost."

Dominik Blei, Head of Development for Patient Assistance Company

"We had two really fantastic days of audit [...] and Mr.[auditor of notified bodies] gave us a huge compliment. Thank you very very much once again for your great work and assistance. Without your help we would probably have failed. With this development plan we have successfully brought a great impression :-)."

Björn Maucher, HIM, Health Information Management GmbH

"In early September we had our first maintenance audit and we passed! Thank you very much also to Mr. Wittorf for your support!"

Lisa Hopp, Head of Quality Management, SUPSmed

"We have done the audit and we "passed". There were no non-compliancy and no suggestions for improvements. The auditor team has especially complimented the QMS technical basic. Big thanks from me and the whole team for your great assistance!"

Klaus Mueller, xmachina GmbH, Heidelberg


Get in touch with us right away so that you can soon achieve a lean MDR-/IVDR-/ISO 13485-compliant QM system!


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