Johner Institut

What Johner Institut does

Johner Institut GmbH, headquartered in Konstanz, Germany and founded in 2005, supports medical device and IVD manufacturers in compiling, reviewing, and improving technical documentation required to bring products to market in the EU, UK, Switzerland, and the US. The company operates as a hybrid regulatory consulting, RegTech software, and training firm built around four pillars: (1) consulting services covering regulatory affairs, quality management systems (ISO 13485, QMSR), technical documentation, clinical evaluation, IT security, and AI strategy; (2) proprietary software products including the Auditgarant guided self-service platform, Regulatory Intelligence, Regulatory Radar, Post-Market Radar (monitoring 10,000+ standards), Regulatory Radar for Pharma, the Guided Clinical Evaluator, and a freemium Post-Market Radar tier; (3) education delivered through the Johner Academy e-learning platform, public seminars, in-house training, the Medical Device Insights podcast, and two 2026 AI training cohorts (AI Lab: The Expedition and Catch the Train); and (4) outsourcing and testing services — Legal Manufacturer, Authorized Representative and QMB roles, IVD performance studies, clinical investigations, biocompatibility, electrical safety and EMC, usability, and penetration testing per IEC 81001-5-1.

Underlying technology combines domain-tuned AI workflows on Azure OpenAI for regulatory document analysis and QMS optimization, automated surveillance across large standards catalogs, and explainability tooling (Layer-Wise Relevance Propagation) for ML-enabled medical devices. The go-to-market blends direct enterprise sales for consulting and outsourcing, self-serve PLG subscriptions for Auditgarant and the Radar suite, freemium top-of-funnel via Post-Market Radar Free, and flagship events (Medical Device Days, Startup Day, World Medical Device Summit) for demand generation. Customers include Alcon, B. Braun, Boehringer Ingelheim, Bosch, Brainlab, Carl Zeiss Meditec, Dräger, Fresenius, GE Healthcare, Hartmann, TÜV SÜD, Bayer, Erbe, and B Medical Systems, alongside a long tail of mid-market and startup manufacturers served through software, training, and micro-consulting channels. Revenue is not publicly disclosed; the company is privately held under founder Prof. Dr. Christian Johner with no external investors, parent company, or acquisition activity on record.

Name

Johner Institut

Legal name

Johner Institut GmbH

Website

https://johner-institut.de

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

51–100 employees

Short description

Johner Institut GmbH is a Konstanz-based consulting, RegTech software, and training firm that helps medical device and IVD manufacturers achieve regulatory compliance in the EU, UK, Switzerland, and the US.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Professional, Scientific, and Technical Services (54), Software Publishers (5132)

SIC

Services-Testing Laboratories (8734), Services-Medical Laboratories (8071)

akta.pro primary industry

Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA) (HLAGAKAF)

akta.pro secondary industries

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC), Project, Process & Quality Certification Prep (PMP, PRINCE2, Lean Six Sigma, ITIL) (EDANAIAE), Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ), QA, Test Automation & Software Quality (Manual/Automated Testing, Performance) (EDABAFAL), Combination Products Regulators (HLAJADAE)

Keywords

• Medical device consulting
• Regulatory affairs services
• RegTech software solutions
• MDR IVDR compliance
• ISO 13485 certification

Headquarters

HQ city

Stuttgart

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Consulting Services: Regulatory affairs consulting, quality management system implementation, technical documentation, market access support, and change management services for medical device manufacturers.
2. Software Subscriptions: Recurring subscription revenue from Auditgarant, Johner Academy, Regulatory Intelligence, Regulatory Radar, and Post-Market Radar products. Minimum one-year terms with automatic annual renewal.
3. Training & Education: Seminars, courses, workshops, and e-learning programs including public events, in-house training, and AI education programs like 'Catch the Train' and 'AI Lab: The Expedition'.
4. Outsourcing Services: Legal manufacturer services, authorized representative services (EU, UK, Switzerland, USA), responsible person services, and QMB outsourcing.
5. Product Testing: Testing services including IVD performance studies, clinical trials, biocompatibility testing, electrical safety & EMC, IT security, and usability testing.

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels10 records

Core offering

Johner Institut sells regulatory affairs consulting, RegTech software subscriptions, AI training programs, and product testing services to medical device and IVD manufacturers. Its core software products (Auditgarant, Johner Academy, Regulatory Intelligence, Post-Market Radar, Regulatory Radar) help manufacturers compile technical documentation, maintain MDR/IVDR/FDA/AI Act compliance, and automate post-market surveillance across EU, UK, Switzerland, and US markets.

Product overview

Johner Institut is a consulting, training, and RegTech software company serving medical device and IVD manufacturers. Its portfolio operates across four main pillars: (1) RegTech software products — including Auditgarant (AI-assisted MDR self-service audit tool), Johner Academy (e-learning platform), Regulatory Intelligence, Post-Market Radar (automated PMS monitoring 10,000+ standards), Regulatory Radar (for MDR and pharma), and Post-Market Radar Free; (2) AI training programs — Johner's AI Lab: The Expedition and Catch the Train, both covering AI Act and ML regulatory requirements with Academy access; (3) consulting services spanning regulatory affairs, quality management (ISO 13485), technical documentation, IT security, and AI strategy; and (4) product testing services (biocompatibility, usability, electrical safety, penetration testing) and outsourcing (Legal Manufacturer, Authorized Representative). All offerings are aimed at helping manufacturers bring safe medical devices to market while navigating complex EU MDR, IVDR, FDA, and AI Act requirements.

Differentiator

Problem solved

Functional benefit

Brands

• Auditgarant: Self-service regulatory compliance tool for MDR certification with document templates and e-learning modules.
• Johner Academy
• Johner MDR Basics
• Regulatory Radar
• Post-Market Radar
• Medical Device Days
• Johner's AI Lab: The Expedition
• Catch the Train

Products and services

• Auditgarant Guided self-service platform that enables medical device manufacturers to independently navigate MDR compliance, prepare and review technical documentation, and pass regulatory audits using templates, e-learning modules, and AI-powered analysis of regulatory requirements and QMS documentation.
• Johner Academy Subscription-based e-learning platform offering video courses and online training on medical device regulatory affairs, quality management, AI Act compliance, and software validation, targeted at MedTech professionals.
• Regulatory Intelligence RegTech software providing real-time monitoring and analysis of regulatory changes across global standards, helping medical device manufacturers maintain compliance with evolving MDR, IVDR, FDA, and AI Act requirements.
• Post-Market Radar Automated Post-Market Surveillance software that monitors over 10,000 standards and regulatory updates, alerting manufacturers to new requirements affecting their products already on the market.
• Regulatory Radar Software that tracks regulatory changes to EU medical device regulations (MDR, IVDR) and international standards, supporting proactive compliance management for medical device manufacturers.
• Regulatory Radar für Pharma Specialized regulatory monitoring software for pharmaceutical products that tracks relevant regulatory changes and updates in the pharma sector.
• Guided Clinical Evaluator AI-supported guided tool that helps manufacturers conduct clinical evaluations of medical devices in compliance with MDR and ISO 14971 requirements.
• Johner's AI Lab: The Expedition Six-month AI training program for MedTech professionals covering AI regulatory requirements (AI Act, ISO 42001), ML development, CSV, LLM applications, with optional Certified MedTech AI Practitioner (Johner Institut) certification. Includes 5 Academy courses, 6 live workshops, community access, optional in-person finale, and 12 months of Academy access.
• Catch the Train Six-month AI training program for MedTech entrepreneurs and companies with 50+ self-study video lessons, 3 expert sessions, and RocketChat community, covering AI and MedTech regulatory topics. Available as individual or 5-person group enterprise package, with 12 months of Academy access included.
• Consulting Services Comprehensive regulatory and quality management consulting including market access and regulatory affairs, management systems (ISO 13485, QMSR), technical documentation, change management, digitalization and AI, and assisted self-service tools for medical device manufacturers.
• Produktprüfungen (Product Testing) Product testing services including IVD performance studies, clinical investigations, biocompatibility testing, electrical safety and EMC testing, IT security testing, usability testing, and usability laboratory rental for medical devices.
• Outsourcing Services Regulatory outsourcing including Legal Manufacturer services (MDR compliance and liability), Authorized Representative services for EU, UK, Switzerland, and USA market access, and regulatory role services such as Responsible Person and QMB outsourcing.
• Penetration Testing (Pentesting) Specialized penetration testing service for medical device software products and infrastructure, conducted according to IEC 81001-5-1 cybersecurity standards, to identify vulnerabilities before regulatory audits.
• Micro-Consulting Quick, free expert support for specific regulatory questions from the Johner Institut team, providing fast answers to concrete compliance challenges from MedTech professionals.
• AI-Angebot (AI-Expertise and AI-Tech Consulting) AI consulting services combining AI strategy and AI technical implementation: helping medical device manufacturers develop compliant AI strategies and implement AI Act requirements (AI-Expertise), as well as validate ML models, apply AI-specific risk management, and document AI-enabled products for regulatory submission (AI-Tech).

Quantifiable outcome

• Post-Market Radar monitors 10,000+ standards automatically
• +2 more outcomes

Named customers18 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability9 records

Feature6 records

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Qserve Group: Specialized medical device regulatory affairs and quality management consulting firm with notified-body-experienced consultants, operating across EU and US. Highly comparable to Johner's regulatory and QMS consulting services.
• Medidee Services: Medical device regulatory and clinical consultancy focused on MDR/IVDR compliance, clinical evaluation, and quality management. Direct competitor for Johner's core consulting mandates with European SMEs and mid-market manufacturers.

Peers

• Emergo by UL: Regulatory affairs and quality assurance consulting for medical device and IVD manufacturers, covering EU, US and international submissions. Directly comparable consulting portfolio, now operating within UL's broader compliance and certification platform.

Broad incumbents

• TÜV SÜD: Global testing, inspection and certification giant acting as an EU MDR/IVDR notified body. Overlaps with Johner on testing, certification support, and authorized representative services, while operating on a much larger global scale.
• BSI Group: Standards body, notified body and certification provider with deep medical device regulatory services. Competes for the same enterprise compliance and certification mandates as Johner, particularly across MDR/IVDR.
• DEKRA: International testing, inspection and certification organization with medical device notified-body services. Comparable to Johner on product testing (biocompatibility, electrical safety) and regulatory pathway support.
• NSF International: Public health and safety organization providing medical device testing, certification, and regulatory consulting. Comparable testing-and-certification footprint, with broader scale and global brand recognition.
• NAMSA: Medical device-focused CRO offering regulatory, clinical, and laboratory testing services. Overlaps with Johner's product testing (biocompatibility, electrical safety) and clinical evaluation / IVD performance work.

Emerging players

• RAPS (Regulatory Affairs Professionals Society): Global membership and training organization for regulatory professionals in medical devices, pharma and biotech. Comparable to Johner's Johner Academy on training and certification, though broader than MedTech-specific.
• Greenlight Guru: RegTech and QMS software platform purpose-built for medical device companies, including quality management, design controls, and risk management. Comparable to Auditgarant as a software-led compliance offering for MedTech manufacturers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• GitHubgithub.com/johner-institut
• YouTubeyoutube.com/channel/UCJKZSKvE6IhWk-0A0ur07OQ
• LinkedInlinkedin.com/company/johner-institut-gmbh
• Facebookfacebook.com/JohnerInstitut

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Johner Institut