Johner Institute (Distributor Requirements Guidance)
Johner Institute GmbH
Johner Institute provides expert guidance on medical device regulations, quality management systems, and software development. They assist manufacturers in navigating complex compliance landscapes for market access.
The Johner Institute specializes in helping medical device manufacturers develop safe products and navigate complex global regulations. They offer expertise in areas such as MDR/IVDR compliance, quality management systems (ISO 13485), risk management (ISO 14971), and software development (IEC 62304). Their services include market access support for US and international markets, IVD admission strategies, and guidance on AI medical devices. They also provide training and consulting to ensure compliance and facilitate market entry. With a mission to help companies develop safe medical products efficiently and promote professional development, Johner Institute acts as a trusted partner for both small and large organizations. They are committed to excellence, honesty, and sustainable problem-solving in the healthcare IT and medical technology sectors.
About
**Who they are**
Johner Institute (Distributor Requirements Guidance) is a consultancy focused on helping medical device manufacturers navigate complex regulatory landscapes. They emphasize developing safe products and bringing them to market efficiently.
**Expertise & scope**
* Guidance on medical device regulations, quality management systems, and software development.
* Assistance for manufacturers in achieving market access.
* Support for understanding and meeting distributor obligations under the MDR.
* Focus on reducing QM burdens and enabling small companies to master regulatory hurdles.
* Development of tailor-made tools, checklists, seminars, and e-learning units.
* Expertise in IT for healthcare and medical device development.
**Reputation / proof points**
* Certified according to ISO 13485:2016 since 2018.
Johner Institute (Distributor Requirements Guidance) is a consultancy focused on helping medical device manufacturers navigate complex regulatory landscapes. They emphasize developing safe products and bringing them to market efficiently.
**Expertise & scope**
* Guidance on medical device regulations, quality management systems, and software development.
* Assistance for manufacturers in achieving market access.
* Support for understanding and meeting distributor obligations under the MDR.
* Focus on reducing QM burdens and enabling small companies to master regulatory hurdles.
* Development of tailor-made tools, checklists, seminars, and e-learning units.
* Expertise in IT for healthcare and medical device development.
**Reputation / proof points**
* Certified according to ISO 13485:2016 since 2018.
Additional information
Johner Institute offers specialized support for understanding the increased requirements for distributors under the Medical Device Regulation (MDR). They aim to clarify these obligations, which can include significant penalties for non-compliance. Their services extend to helping manufacturers understand how these distributor requirements impact them. They provide practical tools and guidance to ensure smooth operations within the supply chain.
Key Highlights
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Provides expert guidance on medical device regulations, quality management systems, and software development.
Source
“Johner Institute provides expert guidance on medical device regulations, quality management systems, and software development.”
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Assists manufacturers in navigating complex compliance landscapes for market access.
Source
“They assist manufacturers in navigating complex compliance landscapes for market access.”
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Offers support for understanding distributor obligations under the Medical Device Regulation (MDR).
Source
“The Medical Device Regulation (MDR) has significantly increased the requirements for distributors.”
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Certified according to ISO 13485:2016 since 2018.
Source
“To meet our own quality requirements, we have established a QM system and have been certified according to ISO 13485:2016 since 2018.”
Certifications & Trust Signals
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Certified according to ISO 13485:2016 since 2018.
Source
“To meet our own quality requirements, we have established a QM system and have been certified according to ISO 13485:2016 since 2018.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking to understand distributor compliance requirements.
- Companies needing guidance on navigating EU medical device regulations.
- Organizations looking to streamline quality management systems.
How engagement typically works
- Consultancy and expert guidance.
- Development of custom tools and resources.
- Educational offerings including seminars and e-learning.
Typical deliverables
- Compliance strategy and guidance documents.
- Checklists and tailored tools for regulatory adherence.
- Training materials and e-learning modules.
- Support for navigating MDR and other medical device regulations.
Good to know
- Best when seeking specialized knowledge on distributor obligations under MDR.
- Suitable for companies prioritizing efficient and sustainable problem-solving in compliance.
HQ:
Konstanz, DE
Languages:
English, German
Timezones:
Europe/Berlin
Status:
listed
Services & Capabilities
Importer & Distributor Compliance Support
Jurisdictions:
EU
Countries:
DE, AT, CH
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
6-25, 26-100
Onboarding time:
2–19 days
Pricing model:
Per project
Starting from:
EUR 1,200
Included services:
Training for economic operator obligations, Compliance gap scan, Audit readiness support
Training Available:
Yes
Template Pack Available:
Yes
Deliverables:
SOPs, Templates pack, Training, Audit support
Training Format:
Both
Role Coverage:
Both
Additional importer_distributor_compliance Details
Role Coverage
Distributor, Importer
Supports MDR
Yes
Supports IVDR
Yes
Onboarding Steps
The provided content does not detail specific onboarding steps, required documents, timelines, or setup processes for engaging their services.
