With InhouseExcellence, medical device manufacturers can avoid high costs for external consultants and accelerate their development by increasing the expertise of their own employees. The service is aimed at employees of medical device manufacturers in the areas of regulatory affairs, quality management, development, product and project management, as well as consultants and notified bodies.
InhouseExcellence is a work-integrated continuing education programme that enables medical device manufacturers to...
InhouseExcellence combines various teaching methods. Thus, participants can acquire the skills they need as quickly as possible to enable the rapid and standards-compliant development of safe, effective and usable medical devices, as well as lean and ‘audit-proof’ documentation; without the expensive external consultants.
InhouseExcellence expands our Auditgarant to include personalised and individual support in the form of face-to-face teaching, webinars and assignments.
| Medium | Description | Goals |
|---|---|---|
| Seminars | In-person events typically offered by the instructors of the Johner Institut in Konstanz. | Provide basic knowledge, foster group cohesion |
| Webinars | Approximately 1-2 hour web conferences where participants can discuss with an instructor and conduct screen sharing. | Answer questions, receive assistance with assignments, delve into topics |
| Video Trainings | Participants automatically become members of Audit Guarantee, providing access to 60+ video trainings. | Acquire domain knowledge, receive assistance with assignments |
| Assignments | Tasks that participants are required to complete, ideally from their direct professional context. | Create documents, review documents, analyze hazards, customize checklists for their own company, acquire competencies and practical experiences, carry out company tasks |
| Presence Phase | Workshops lasting two to three days in Konstanz. | Present participants' solutions, learn to assess others' results, delve into topics, answer questions, gain confidence in presenting |
| Exams | Approximately 3-hour examinations that, along with assignments, form the basis for grading. | Ensure learning success |
Participants adjust the intensity of their own qualification themselves, for example, to their workload and individual learning progress. One quarter or more should be estimated per module. The process shown in the adjacent figure is recommended for each module.
InhouseExcellence consists of the following modules
You can take these modules individually and independently of each other.
In the InhouseExcellence training course, participants learn
The newly qualified experts will be able to use their expertise to
This means that participants acquire not only specialist knowledge but also methodological skills.
The training should be seamlessly integrated into everyday work and promote the work of future experts during their training rather than hindering it through absences.
Furthermore, the training programme aims to minimise the costs of external consultants and build up internal expertise, thereby increasing the value of employees and thus the company.
InhouseExcellence is aimed at medical device manufacturers, consulting firms and notified bodies that wish to train their own employees in the areas of regulatory affairs, quality management and development. It is particularly suitable for employees who are or will be responsible for the following tasks:
The training is therefore not only aimed at employees in the Regulatory Affairs and Quality Management departments, but also explicitly at developers (architects, programmers, engineers, testers) as well as usability and requirements engineers. Employees who are responsible for project and process management are also part of the target group.
After successfully passing the exam, participants receive a certificate and a detailed assessment of their performance, highlighting their strengths and areas for improvement. This enables companies to meet the requirements of the FDA, among others, for employee qualification and continuous knowledge ‘refresher’ training.
Phone
+1 (240) 638 27 09
Contact Form
Currently, we offer the training program as a closed beta version to a limited number of companies only.
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