We free you from unnecessary paperwork so your team can finally work productively. That will ensure noticeable satisfaction and reduce effort and costs.
Efficient processes mean better cooperation and shorter time to product approval, which is crucial for your competitiveness and business success.
Our team will ensure that your QM system meets all the relevant requirements. That means less stress for you during the certification process and a lower risk of non-conformities in upcoming audits.
From now on, your team and managers will know where things are going wrong and can be optimized. This will enable you to use the QM system as a tool for safe processes and lower error rates in the future.
For many medical and IVD medical device manufacturers, the QM system feels like a bloated bureaucratic construct that causes unnecessary work and hinders productivity. The cumbersome QM processes annoy the team and delay the market launch of devices.
Despite all these QM efforts, there is often additional uncertainty about whether the QM system fulfills all the regulatory requirements. The consequences: stress and inconvenient non-conformities during audits.
We help you develop and establish a QM system that is tailored to your company, practice-oriented, and therefore practicable – regardless of whether you are a start-up or a large corporation. We are also happy to use a digital tool of your choice.
We simplify and optimize your QM specifications and system components step by step. This will make your processes simpler, more efficient, and “audit-proof.”
We work closely with your team to identify the biggest obstacles and compliance issues. Afterward, you know exactly what to do to eliminate them.
We ensure that your project runs smoothly and you achieve the defined objectives on time. We also train your teams to understand the requirements, successfully implement the new processes, and develop them further.
Our team will help you set up a lean process for validating relevant computer systems and documenting the process in a regulatory-compliant manner.
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We can create integrated management systems or help you merge different management systems upon request.
Experienced and Competent Auditors
Our team consists of experienced experts, auditors, and even members of standards bodies who help develop the regulatory requirements and can, therefore, best prepare you for audits.
Worldwide Conformity
We focus on ISO 13485 certification as well as other requirements such as MDSAP or 21 CFR Part 820, ensuring that your QM system meets all requirements worldwide without unnecessary additional effort.
Broad Expertise
Our comprehensive expertise extends far beyond QM – from approval to clinical strategies and biological safety to artificial intelligence. This means we can also help you meet any other regulatory requirements.
Proven Templates
Our experts provide templates that have proven themselves in countless audits. This saves time and money and gives you extra regulatory safety You don't always have to start from scratch.
Looking to the Future
At the Johner Institute, we have a clear vision for modern QM systems. This means you are perfectly prepared for tomorrow – digital transformation included. Simply fit-for-future.
Contact us right away to discuss the best strategy for your quality management system.
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+49 7531 94500 20
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We review your management system with a trained external perspective. We help you eliminate any problems we find in a targeted manner. You will then be ready for audits by authorities and notified bodies.
As your external quality management representative (QMR), we handle much of the QM work for you, which gives you continuity and regulatory safety.
Save yourself the trouble of having your own QM system and slip under our umbrella. We also act as your legal manufacturer. This will get your devices into the market as quickly as possible.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops in the field of quality management are the key.
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