Legal Manufac­turer EU

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The Johner Institute is your legal manufacturer for medical devices in Europe

Faster Market Access

Significantly shorten your time to market with our proven processes and readily available resources. No more delays due to regulatory hurdles.

Focus On Your Core Business

Increase your productivity by focusing on product development and sales. We'll take care of all regulatory compliance.

Cost Savings and Planning Security

Save the costs of your own regulatory affairs staff and QM system. Benefit from plannable costs without any expensive surprises.

Minimized Compliance Risks

Rest assured that your medical devices meet all legal requirements and will pass audits with flying colors.

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Regulatory safety and market access in the EU without needing own resources

The increasing MDR and ISO 13485 require­ments pose major challenges for many manufacturers.
A lack of capacity, expertise, or unsuitable QM systems delay the market launch of their medical devices and jeopardize their business success. 

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We take full regula­tory responsi­bility for your medical devices as legal manufacturer

Our legal manufacturer service includes:

  • Complete Project Management: From project planning and coordination to monitoring results – we control all activities for you
  • Technical Documentation: We create and check your technical documen­tation and close existing gaps
  • QM System and Audits: Benefit from our established QM system and our audit expertise
  • Communication with Authorities: We take over the communi­cation with authorities and notified bodies
  • Post-Market Surveillance: We collect and analyze all relevant data after market launch and take the necessary measures as required. 
Ready for a smooth path to MDR-compliant medical devices?

​​​​​​​Contact us ​​​​​​​right away to request a first meeting. 

 

Contact us, we're happy to help!
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+1 (240) 638 27 09

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