Quality Management Systems: Precondition for Market Approval
Quality Management Systems: Precondition for Market Approval
Successfully pass audits and inspections instead of causing quality bureaucracy
Most companies find quality management audits and FDA inspections stressful. Our regulatory affairs experts and lead auditors will help you to quickly
- pass these audits (ISO 13485, ISO 9001) and inspections (21 CFR part 820),
- establish concise and customized quality management systems (QM systems),
- streamline your existing QM system, and
- achieve regulatory compliance fast, with minimum efforts and without having to read hundreds of regulatory documents
Precise and streamlined processes will help not only to achieving regulatory compliance but also to developing high quality products in time and budget.
Create QM-Systems (ISO 13485)
Our auditors and QM experts have assisted literally hundreds of medical device companies to pass audits and inspections successfully (100% success rate)
Mock Audits & Inspections of QM-Systems
Avoid uncertainty or even fear of audits and inspections. Our ISO 13485 lead-auditors perform a Mockup audit and perfectly prepare you for the next audit and inspection.
External Quality Management Representative
You do not have to do everything yourself: We will gladly support you as an external QM representative.
How Johner Institute helps
Read more about how we can help to
- establishing your quality management (QM) system
- challenging your QM systems with mock-up audits and preparing it for the next audit and inspection
- overcoming shortage of personnel e.g. by acting as your external quality representatives.
Contact us now and learn how we can help to develop and maintain your quality management system!
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
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