CJ Managementservice 
•MDR • FDA • ISO 13485 • ISO 9001•  

Our Workshop Program 

• On-Site or Online • Tailored •



• Customized Workshops – Tailored to Your Need • 


We offer practical workshops designed entirely around your requirements:

Participation can take place individually, in teams, or company-wide.

Choose an online workshop if you want to join while traveling, in the office, or conveniently from home.

We are also happy to visit you on-site to interactively address your specific challenges. On request, we adapt the content to your exact requirements.
 
This way, you gain precisely the knowledge that moves you forward – efficient and easy to understand. Choose the topic and training format that suits you best!


  • We also offer our workshops online – join conveniently from home, on business trips, or from the office! Topics are available in Basic, Plus, and Premium packages: 8D, ISO 9001, ISO 13485, CAPA, MDR.
  • We conduct our workshops at your facilities, tailored to your employees and specific needs. Upon request, we train based on individual challenges from your daily operations, covering topics such as ISO9001, ISO13485, CAPA, MDR, and 8D problem-solving


Contact Us to Schedule an Appointment or Receive Expert Advice:
📞 +49(0) 170-260-52-47
Knowledge Made Simple – With CJ Management Service

Basis • Plus • Premium Workshop

•Basis
Online Intros 
•Plus
Customized Client Training + Templates
•Premium
 Interactive Live Workshops + Process Implementation at the Client Site



Each topic is available as a Basic • Plus • Premium Workshop 


Topic

Description

Duration

  • 8D-Report

Understand the purpose and benefits of the 8D method and recognize 8D as an integral part of quality management systems.

Contents:
-Overview: The 8 disciplines in detail
-Methods and tools for support
-Practical creation of an 8D report
-Communication with clients and suppliers
-Tools and templates


1 d

  • CAPA

-Introduction to CAPA
-Regulatory foundations
-CAPA process and workflow
-Methods for root cause analysis
-Development of effective actions
-Documentation and follow-up
-Integration into the quality management system
-Practical exercises and case studies
-Common mistakes & best practices
-Conclusion & transfer into practice


1d

  • MDR

-Participants become familiar with the key requirements of the MDR (EU) 2017/745, understand their impact on the organization, and learn how to implement them within their own area of responsibility.
-Introduction to the MDR
-Classification of medical devices
-Conformity assessment & CE marking
-Post-market surveillance (PMS) & vigilance
-UDI & Eudamed
-Role of economic operators


1 d

  • ISO 13485

Participants understand the requirements of ISO 13485:2016, recognize their significance for the organization, and learn how to implement them in their daily work


2 d

  • ISO 9001

Participants understand the structure, content, and requirements of ISO 9001:2015 and learn how to apply the standard to their company’s processes and management system.
-High Level Structure (HLS)
-The 7 quality management principles
-Common mistakes & best practices


2 d


 
 
 
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