Johner Institut GmbH
Business-Consulting-and-Services
Website
Company Tagline
Effortlessly navigate the medical device approval processes and market and quickly market your device world-wide.
Industry Category
Business Keywords
Company Description
Johner Institut GmbH, a leading provider of business consulting and services, empowers medical device manufacturers to navigate complex regulatory landscapes and accelerate global market access. With a focus on excellence and precision, Johner Institut GmbH offers comprehensive support in compiling, reviewing, and enhancing technical documentation, including risk management files, usability files, and software documentation. Johner Institut GmbH is dedicated to ensuring that its clients meet the highest standards of quality and compliance.
Located at Reichenaustraße 39a, Konstanz, Baden-Württemberg 78467, DE, Johner Institut GmbH excels in establishing, auditing, and refining quality management systems to align with ISO 13485 and 21 CFR part 820 standards. The institute conducts thorough usability testing in both Europe and the USA, coupled with expert planning and execution of clinical investigations. This ensures that medical devices are not only compliant but also user-centric and effective.
Johner Institut GmbH’s commitment extends to post-market surveillance and regulatory affairs updates, ensuring sustained compliance and market relevance. By focusing on these critical areas, Johner Institut GmbH enables medical device companies to thrive in a competitive and highly regulated environment. We invite the management of Johner Institut GmbH to create a customized and exclusive company showcase and product listing on our platform to further amplify their market presence.
Johner Institut GmbH, un fournisseur leader de services et de conseils aux entreprises, permet aux fabricants de dispositifs médicaux de naviguer dans des environnements réglementaires complexes et d'accélérer leur accès au marché mondial. En mettant l'accent sur l'excellence et la précision, Johner Institut GmbH offre un soutien complet dans la compilation, la révision et l'amélioration de la documentation technique, y compris les dossiers de gestion des risques, les dossiers d'utilisabilité et la documentation logicielle. Johner Institut GmbH s'engage à garantir que ses clients respectent les normes de qualité et de conformité les plus élevées.
Situé à Reichenaustraße 39a, Konstanz, Baden-Württemberg 78467, DE, Johner Institut GmbH excelle dans l'établissement, l'audit et le perfectionnement des systèmes de gestion de la qualité afin de s'aligner sur les normes ISO 13485 et 21 CFR partie 820. L'institut effectue des tests d'utilisabilité approfondis en Europe et aux États-Unis, ainsi qu'une planification et une exécution expertes des études cliniques. Cela garantit que les dispositifs médicaux sont non seulement conformes, mais aussi centrés sur l'utilisateur et efficaces.
L'engagement de Johner Institut GmbH s'étend à la surveillance post-commercialisation et aux mises à jour des affaires réglementaires, garantissant une conformité soutenue et une pertinence sur le marché. En se concentrant sur ces domaines critiques, Johner Institut GmbH permet aux entreprises de dispositifs médicaux de prospérer dans un environnement concurrentiel et hautement réglementé. Nous invitons la direction de Johner Institut GmbH à créer une vitrine d'entreprise et une liste de produits personnalisées et exclusives sur notre plateforme afin d'amplifier davantage leur présence sur le marché.
Key Personnel / Employees
Compare Companies Side by Side
Compare Johner Institut GmbH with 3 companies in Business-Consulting-and-Services
| Comparison Field |
Johner Institut GmbHMain Company |
ApotechView Profile |
QualioView Profile |
IMed Consultancy LtdView Profile |
|---|---|---|---|---|
|
Founded Year
|
— | 2020 | 2012 | 2012 |
|
Company Size
|
— | 11-50 | 51-200 | 11-50 |
|
City
|
Konstanz, Baden-Württemberg | London, England | San Francisco, California | Bloxham, England |
|
Country
|
Germany | United Kingdom | United States | |
|
Skills & Keywords
Comparing with main company
|
29 Total Skills
Medical Device Consulting
Regulatory Compliance
Quality Management Systems
Usability Testing
Risk Management
Clinical Investigations
Post-Market Surveillance
Clinical Evaluation
IEC 62304
Technical Documentation
Human Factors Engineering
Quality Management
Electrical Safety
Clinical Investigation
Regulatory Updates
Medical Device Approval
Elearning
ISO 14971
IT-Security
510(k)
ISO 13485
Audit
IEC 62366-1
Seminars
CE Marking
MDR
IVDR
FDA
Product Testing
|
17 Total
17 Unique
Unique Skills:
Biotech
Commissioning & Qualification
Computer Systems Validation
EMA
GCP
GCP Audit
+11
|
27 Total
1 Common
26 Unique
Match
3%
Common Skills:
Regulatory Compliance
Unique Skills:
BioTechnology
Cannabis
Contract Research Organizations
CRO
Design Control
Document Control
+20
|
16 Total
16 Unique
Unique Skills:
21 CFR Part 820
510k
Auditing
Clinical Evaluations
Global Registrations
Health Canada
+10
|
4
Total Companies2012
Oldest Founded3
Countries86
Unique SkillsSimilar Companies
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Alternative Company Names
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