Johner Medical GmbH

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.

Overview of the services of Johner Medical GmbH

Virtual Manufacturing / Own-brand Labeling

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.

Your benefits

• You can focus on your core competences, i.e. the development and manufacturing
• You do not have to care about the approval and market surveillance
• You bring in your own branding and distribute the product accordingly

Elektronisches Qualitätsmanagementsystem - JCeQMS

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.

Your benefits

• All regulatory requirements as well as a comprehensive and transparent document control incl. detailed workflow for important processes like training, CAPA and medical device reporting/vigilance are mapped
• Due to digital links of all documents and tasks storage of documents is not needed. Information is found rapidly and traceable.
• The systems can be adapted to your needs and requires low running costs.

Externe PRRC

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.

Your benefit

• You save time and costs for the setting up and training, resp. of a PRRC.
• Without any delay you have access to qualified and experienced experts supporting you with advice and action
• The application of an external PRRC for small and midsized companies as well as start-ups has proven successful numerous times.

Representative for EU, CH, UK and NZ

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.

Your benefit

• We enable the legal placing on the market of your products if your organization is located outside the EU
• We take over communication with the authorities
• We verify if your Declaration of Conformity and the technical documentation is complying with the legal requirements
• We ensure the compliance with the regulatory requirements for you.
• We perform audits with the economic operators involved.
   

External Quality Management Representative

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.

Your benefit

• We create the greatest possible relief for you so that you can concentrate on your core business.
• We offer you security through our expertise and many years of experience from numerous projects with different companies.
• We ensure the conformity of your quality management system to standards.