The Johner Medical GmbH was founded in December 2019 as a 100% subsidiary of Johner Institut GmbH. Johner Medical takes over regulatory roles for you required by the MDD, MDR, IVDD and IVDR within the European Economic Area. Possible regulatory roles are those of the legal manufacturer or the authorized representative or the person responsible for regulatory compliance.
We place your products under our own name on the market, i.e. we take over the regulatory responsibility.
Thereby you save money, costs and resources which you need to raise in order to get the certification, to run a complete quality management system and to get audits performed by Notified Bodies.
We provide an electronic quality management system to your company which is based on Confluence and Jira. Moreover, we offer a requirement workshop and trainings for the application of the system.
You save time, costs and resources in order to install a quality management system compliant with the standards; simultaneously you get the security that all regulatory requirements are mapped.
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All manufacturers need to appoint a person responsible for regulatory compliance (PRRC).
We take over this task of the PRRC according to Art. 15 MDR/IVDR. As an external PRRC we offer you the security by our expertise and experience from numerous projects.
All manufacturers located outside the union of the target market mandatorily need a so-called representative for placing a product on the market within the union.
We take over the role and responsibility of the representative for the EU, Switzerland, Great Britain and New Zealand for you. Thereby you are saving effort for the education of the appropriate personal as well as the organizational expense for an affiliate within the respective union.
The construction of a QMS is very time consuming. Particularly for small and mid-sized companies and start-ups the use of an external Quality Management Representative (QMR) is proven numerous times in this respect.
We take over the quality management tasks of your company according to ISO 13485:2016 section 5.5.2. Thereby you are saving valuable time and costs needed for the training of an internal QMR.