Johner Institut
Johner Institute
★★★★★
4.7
/ 5
•
69 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. They focus on helping companies develop safe products and bring them to market despite regulatory hurdles.
**Expertise & scope**
* Develops IEC 62366-1 and FDA-compliant usability files.
* Performs usability evaluations for active and non-active medical devices across Classes I to III.
* Offers formative and summative usability evaluations, including heuristic evaluations and usability testing.
* Provides guidance on Instructions for Use (IFU) and User Interface (UI) design.
* Supports market access in Europe and the US.
**Reputation / proof points**
* Certified according to ISO 13485:2016 since 2018.
* Operates usability labs in Frankfurt and the USA.
* Offers a large number of templates to expedite documentation creation.
* Focuses on sustainable problem-solving and sincere assistance.
Johner Institut is a regulatory partner for medical device manufacturers, offering expert guidance to navigate complex regulations and achieve faster market access. They focus on helping companies develop safe products and bring them to market despite regulatory hurdles.
**Expertise & scope**
* Develops IEC 62366-1 and FDA-compliant usability files.
* Performs usability evaluations for active and non-active medical devices across Classes I to III.
* Offers formative and summative usability evaluations, including heuristic evaluations and usability testing.
* Provides guidance on Instructions for Use (IFU) and User Interface (UI) design.
* Supports market access in Europe and the US.
**Reputation / proof points**
* Certified according to ISO 13485:2016 since 2018.
* Operates usability labs in Frankfurt and the USA.
* Offers a large number of templates to expedite documentation creation.
* Focuses on sustainable problem-solving and sincere assistance.
Additional information
Johner Institut emphasizes accelerating market entry and minimizing costs associated with usability engineering documentation. They aim to reduce stress during audits and approvals by managing participant recruitment, test planning, execution, and documentation. Buyers can leverage their expertise to ensure user-friendly medical devices, potentially leading to market revolution. The institute also supports professional and personal development within the healthcare IT and medical technology sectors, offering part-time Master's courses.
Key Highlights
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Develops IEC 62366-1 and FDA-compliant usability files.
Source
“Create IEC 62366-1 and FDA-compliant usability files in no time at all.”
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Offers usability evaluations for all medical device classes.
Source
“The Johner Institute plans and performs usability evaluations not only for active medical devices, but for all medical devices of Classes I to III”
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Certified according to ISO 13485:2016 since 2018.
Source
“we have established a QM system and have been certified according to ISO 13485:2016 since 2018.”
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Operates usability labs in Frankfurt and the USA.
Source
“Make use of our usability labs (in Frankfurt and in the USA).”
Certifications & Trust Signals
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Certified according to ISO 13485:2016 since 2018.
Source
“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 regulatory compliance support.
- Companies needing assistance with human factors and usability engineering.
- Firms aiming for faster market access in the EU and US.
How engagement typically works
- Collaborative partnership for regulatory guidance.
- Provision of templates and expert execution of usability processes.
- Consulting and tailored tools, checklists, seminars, and e-learning.
Typical deliverables
- IEC 62366-1 and FDA-compliant usability files.
- Usability evaluation reports (formative and summative).
- Test plans and execution summaries.
- Guidance on Instructions for Use.
Good to know
- Best when requiring specialized expertise in human factors and usability for medical devices.
HQ:
Konstanz, DE
Languages:
English, German
Timezones:
Europe/Berlin
Claim 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
The provided content does not detail specific onboarding steps, required documents, timelines, or setup processes for engaging their services.
Coverage Details
PRRC availability set to Extended hours with defined escalation path (seed summary).
Supports MDR
Implied through general regulatory support for medical devices in the EU.
Regulatory Experience
The website indicates extensive experience in medical device regulations, particularly concerning usability engineering (IEC 62366-1) and FDA compliance. It also mentions experience with medical software development and supporting notified bodies.
Supports IVDR
Implied through general regulatory support for medical devices in the EU.
PRRC Qualification Summary
The provider's website content does not explicitly detail the PRRC's specific qualifications (e.g., degrees, years of experience in regulatory affairs). However, it emphasizes extensive experience as developers of medical software and instructors for notified bodies.
Device Classes Supported
Class I to III
