Johner Institut
Johner Institute is dedicated to helping medical device companies bring their products to market quickly and efficiently, despite regulatory challenges. They offer consulting, technical documentation, product testing, and training services to support compliance with international standards and regulations. The institute also provides digital solutions, seminars, and events to support continuous education and compliance. Their mission is to facilitate innovation and ensure safety in medical device development and regulation.
Industries
Nr. of Employees
medium (51-250)
Johner Institut
Stuttgart, Baden-Wurttemberg, Germany, Europe
Products
Automated regulatory monitoring platform (Regulatory Radar)
Software to monitor and prioritise regulatory changes and evaluate their impact on products and processes.
Automated post-market surveillance platform (Post-Market Radar)
Digital toolset for automated post-market surveillance to support PMS/PMCF/PMPF obligations.
Electronic Quality Management System (eQMS) platform
Cloud-based digital quality management system to manage documents, processes and audit readiness.
E-learning and audit-preparation platform (audit templates and courses)
Online platform providing courses, templates and guided content to prepare staff and organisations for audits and regulatory tasks.
Starter and AI Act kits (starter resources and checklists)
Downloadable starter kits and checklists providing overviews of regulatory pathways and initial steps for AI Act and other regulatory topics.
AI/ML regulatory checklist and audit-readiness guideline
A lifecycle-focused guideline and checklist for AI/ML in medical devices and IVDs that compiles regulatory requirements, standards alignment and suggested audit questions to support documentation and reviewer expectations.
Automated regulatory monitoring platform (Regulatory Radar)
Software to monitor and prioritise regulatory changes and evaluate their impact on products and processes.
Automated post-market surveillance platform (Post-Market Radar)
Digital toolset for automated post-market surveillance to support PMS/PMCF/PMPF obligations.
Electronic Quality Management System (eQMS) platform
Cloud-based digital quality management system to manage documents, processes and audit readiness.
E-learning and audit-preparation platform (audit templates and courses)
Online platform providing courses, templates and guided content to prepare staff and organisations for audits and regulatory tasks.
Starter and AI Act kits (starter resources and checklists)
Downloadable starter kits and checklists providing overviews of regulatory pathways and initial steps for AI Act and other regulatory topics.
AI/ML regulatory checklist and audit-readiness guideline
A lifecycle-focused guideline and checklist for AI/ML in medical devices and IVDs that compiles regulatory requirements, standards alignment and suggested audit questions to support documentation and reviewer expectations.
Services
Advisory services for developing regulatory strategies and preparing submissions for EU, US and other markets.
Creation and review of technical files, clinical evaluation reports, risk management documentation and coordination of biocompatibility testing strategies.
Support for clinical evaluation planning, systematic literature searches (PICO), study design and partner selection to generate clinical evidence.
Implementation and operation of PMS systems, PMCF planning, PSUR/PMS report preparation and statistical trend analysis.
Advisory services for chemical characterization (ISO 10993-18), toxicological risk assessment (ISO 10993-17), cytotoxicity testing (ISO 10993-5) and GLP-related requirements.
Consulting for IVD classification, analytical and clinical performance assessment and IVDR-compliant documentation preparation.
Advisory services for developing regulatory strategies and preparing submissions for EU, US and other markets.
Creation and review of technical files, clinical evaluation reports, risk management documentation and coordination of biocompatibility testing strategies.
Support for clinical evaluation planning, systematic literature searches (PICO), study design and partner selection to generate clinical evidence.
Implementation and operation of PMS systems, PMCF planning, PSUR/PMS report preparation and statistical trend analysis.
Advisory services for chemical characterization (ISO 10993-18), toxicological risk assessment (ISO 10993-17), cytotoxicity testing (ISO 10993-5) and GLP-related requirements.
Consulting for IVD classification, analytical and clinical performance assessment and IVDR-compliant documentation preparation.
Expertise Areas
- Regulatory affairs and market access (MDR, IVDR, FDA and international registrations)
- Technical documentation and clinical evaluation
- Post-market surveillance, PMCF and safety reporting
- Software as a Medical Device (SaMD) engineering and IEC 62304 compliance
Key Technologies
- Regulatory intelligence and monitoring platforms
- Automated post-market surveillance and signal detection systems
- Electronic quality management systems (eQMS)
- IEC 62304-aligned software development processes
News & Updates
Medical Device Days
Annual speed-mentoring conference in Berlin, providing answers on all topics related to medical devices.
Institutstag
Academic summer festival with congress and festive evening, a day for mind, body, and soul.
Medical Device Summit
Conference focusing on the latest developments and regulatory updates in medical devices.
Start-up Day
Event dedicated to innovative start-ups in the medical device sector.
In 7 steps to a medical device
A guide on how to bring a medical device to market quickly and legally compliant, outlining seven essential steps.
Regulatory update: Staying current with requirements
An overview of how manufacturers can keep up with changing regulatory demands in the medical device industry.
Medical Device Days
Annual speed-mentoring conference in Berlin, providing answers on all topics related to medical devices.
Institutstag
Academic summer festival with congress and festive evening, a day for mind, body, and soul.
Medical Device Summit
Conference focusing on the latest developments and regulatory updates in medical devices.
Start-up Day
Event dedicated to innovative start-ups in the medical device sector.
In 7 steps to a medical device
A guide on how to bring a medical device to market quickly and legally compliant, outlining seven essential steps.
Regulatory update: Staying current with requirements
An overview of how manufacturers can keep up with changing regulatory demands in the medical device industry.