Legal Manufacturer EU
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
Stay calm – knowing that your medical devices meet all regulatory requirements and will pass audits with flying colors.
Regulatory certainty 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.
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.
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