Johner Institut
Johner Institute
★★★★★
4.8
/ 5
•
10 reviews
Johner Institute is your regulatory partner for medical device manufacturers, offering expert guidance to navigate complex regulations and achieve faster market access.
The Johner Institute specializes in helping medical device manufacturers overcome regulatory challenges and bring safe products to market faster. They offer a free AI Act Starter Kit, providing an overview of new regulations and essential guidance for AI-based medical devices. Their experts offer free, no-obligation answers to your questions within 48 hours. Stay updated with their newsletter on Medical Device and IVD industry changes. Leveraging cutting-edge AI technology, they analyze vast regulatory data to provide accurate, up-to-date information for your product portfolio. Enhance your medical device skills with their comprehensive training options, from quick lessons to certifications, ensuring you stay current in the industry. They safely guide you through the complex landscape of laws and regulations, ensuring global market access for your medical devices.
About
**Who they are**
Johner Institut is a regulatory partner for medical device manufacturers, offering expert guidance to navigate complex regulations and achieve faster market access.
**Expertise & scope**
* Specializes in regulatory roles for medical devices.
* Provides guidance on complex regulations.
* Focuses on enabling faster market access for medical devices.
* Coverage includes the EU market.
* Services are available in English and German.
**Reputation / proof points**
* Operates as a regulatory partner for medical device manufacturers.
Johner Institut is a regulatory partner for medical device manufacturers, offering expert guidance to navigate complex regulations and achieve faster market access.
**Expertise & scope**
* Specializes in regulatory roles for medical devices.
* Provides guidance on complex regulations.
* Focuses on enabling faster market access for medical devices.
* Coverage includes the EU market.
* Services are available in English and German.
**Reputation / proof points**
* Operates as a regulatory partner for medical device manufacturers.
Additional information
Johner Institut emphasizes its role as a dedicated regulatory partner for medical device manufacturers. Their services are designed to simplify the navigation of intricate regulatory landscapes, ultimately aiming to accelerate the process of bringing medical devices to market. They offer support across the European Union and communicate fluently in both English and German, facilitating clear communication for international clients.
Key Highlights
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Offers expert guidance for medical device manufacturers.
Source
“Johner Institute is your regulatory partner for medical device manufacturers, offering expert guidance to navigate complex regulations and achieve faster market access.”
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Focuses on enabling faster market access for medical devices.
Source
“Johner Institute is your regulatory partner for medical device manufacturers, offering expert guidance to navigate complex regulations and achieve faster market access.”
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Provides regulatory support with EU coverage.
Source
“Coverage: EU”
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Services are available in English and German.
Source
“Languages: English, German”
Certifications & Trust Signals
- Offers specialized services for regulatory roles like PRRC Source
- Provides training on critical medical device regulations (FDA, AI Act, etc.) Source
- Assists in bringing medical devices to market quickly and compliantly Source
- Focuses on ensuring medical devices are safe and standard-compliant Source
Buyer Snapshot
Best for
- Medical device manufacturers seeking regulatory guidance.
- Companies aiming for faster EU market access.
How engagement typically works
- Expert guidance and partnership.
- Support for navigating complex regulations.
Typical deliverables
- Regulatory strategy and advice.
- Market access facilitation.
Good to know
- Best when requiring EU-specific regulatory support.
HQ:
Konstanz, DE
Languages:
English, German
Timezones:
Europe/Berlin
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
EU, GB, CH, US
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 3,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Availability Hours:
Business hours
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
PRRC Qualification Summary:
The Johner Institute helps medical device manufacturers navigate regulatory challenges and bring safe products to market faster. They offer expertise in AI Act compliance, regulatory intelligence, and medical device university programs. They also specialize in Human Factors/Usability Engineering, creating IEC 62366-1 and FDA-compliant usability files, and conducting formative and summative evaluations. Their services cover all medical device classes (I to III) and IVDs, ensuring global market access and accelerating product development. They provide tailored advice, tools, seminars, and e-learning units, with a focus on professional and personal development for those in the medical device industry.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Contact via online form, email, or phone.
Coverage Details
PRRC availability set to Extended hours with defined escalation path (seed summary).
Supports MDR
true
Regulatory Experience
Implied extensive experience in medical device regulations.
Supports IVDR
true
PRRC Qualification Summary
Expert guidance for regulatory roles.
