Johner Institut
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The independent review by our experienced experts assures you and the notified bodies that there are no major gaps in the documentation or the process landscape, paving the way for a successful conformity assessment.
Our readiness certificate proves that your conformity assessment is promising. Authorities and notified bodies have valued our expertise for years. We evaluate objectively and according to the same standards as a notified body.
The conformity assessment process – from the correct application to the final feedback from the notified bodies – can take several months or, in the worst case, several years. Our readiness check ensures you are spared avoidable queries, resubmissions, and correction loops.
Our readiness check ensures that the notified bodies can carry out your conformity assessment without significant non-conformities. That means faster assessment of your devices and processes and the green light for your planned device approval.
The notified bodies generally determine the order in which the conformity assessments are carried out. However, capacities are often limited, which is why applications from manufacturers with uncertainties regarding the required effort or concerns about the outcome are often pushed further back into the queue. As a result, in some cases, medical device and IVD manufacturers have been waiting months for feedback or may even be rejected by the notified body.
Our experts conduct a mock conformity assessment of your QM system and a technical documentation sample. If the quality is sufficient, we will issue you with a certificate that you can submit to the notified bodies.
We proceed as follows:
Note: For manufacturers without previous experience with conformity assessment by notified bodies, we first conduct a preliminary review of the structure and completeness of the most important documents. You will then receive a report that may include recommendations for action before we proceed with the detailed inspection.
Contact us if you would like a readiness check by our experts to gain certainty for your upcoming conformity assessment.
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+49 7531 94500 20
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