Our auditors and QM experts have assisted literally hundreds of medical device companies to pass audits and inspections successfully (100% success rate) by:
With our help you will
The costs for establishing an ISO 13485-compliant quality management system depend on factors such as:
However, because we have already assisted over 100 companies and we have a clear focus on small and medium size companies, we can assess the efforts precisely. Typically, it takes us between 7 and 14 days to compile the quality manual, including all procedures, templates and forms.
We are so fast for several reasons:
A typical project looks like this
Contact us now! We are happy to answer your questions and discuss with you the best way to establish your quality management system.
“Without your competent and highly efficient consulting, the certification would not be possible. Also the team work with Mr. Thern, Mr. Geis, Mr. Gerhart, was really goal oriented and pleasant- and i have learned so much!”
Dr. Niels Bojunga, Molecular Health
"Hi Mr. Prof. Dr. Johner,
I have attached the PDF-File of our certificate as an evidence of a successful certification according to ISO 13485.
Once again thank you very much for your active support. Without it we would probably not able to make it further. [...]
Your [QM Officer], Small Medical Product Manufacturers
"With practical help from Professor Johner and his team, we managed to develop a ‘liveable’ QM System 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 Company for Patients Help
"Beginning of September we had our 1st maintenance audit and had also passed this one! I would like to thank you and and also Mr. Waitron for the support!”
Lisa Hopp, Head of QM, SUPSmed
“We had two really great audit days […] and Mr. [Auditor from the notified bodies] had complimented our company. Thank you very very much once again for an excellent work and assistance. Without your help we would possibly fail. We made a good impression with the development plan :-).”
Björn Maucher, HIM, Health Information Management GmbH
“Our audit is done and we “passed”. There was no non-compliancy and tips regarding potential improvements. The (Auditor) team had particularly complimented the technical basic of the QMS.
In this case, big thanks to you from me and the whole team for a great assistance!"
Klaus Mueller, xmachina GmbH, Heidelberg