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

Quality Management 

DIN EN ISO13485 • DIN EN ISO 9001



•We Step In Wherever You Need Us•

Coaching, consulting, and addressing bottlenecks 

- short-term or long-term - 

Benefit from our expertise and flexibility

 - from individual tasks to full-service solutions - 

Leverage our Capabilities

 - As a Package or Based on Effort! - 

Ideal for SMEs, start-ups, and family businesses!

  • Individually tailored consulting and support in quality management
  • We step in when a QMR has resigned, provide support during excessive workload, bridge gaps, and train new Quality Management Representatives.
  • We help you build a quality management system from the ground up and support you through to certification.
  • As an external QMR or as a temporary service, we help you navigate audits. We support you during the preparation phase and throughout the audit itself.


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

QMR Compact

External Quality Management Representative

QM-as-a-Service

Build your own service package from our listed options

MDSAP
Faster market approval – reduced audit times 
Recognized in
• Japan – Canada – USA – Brazil – Australia •

„Ready for CE"

Perfect for start-ups and small businesses
• We provide initial support – so you can get started •

Interim Management & Coaching

Swift solutions in urgent situations and smooth onboarding



Product



Description


  • „Ready for CE"

-Audit-ready implementation of a quality management system including a quality manual (ISO 13485)
-Technical file in accordance with MDR requirements for your product


  • QM-as-a-Service



 Compilation of Desired Services:
- Implementation and maintenance of ISO 9001 / ISO 13485 / MDSAP
- Internal audits and audit preparation
- Assumption of partial areas within quality management
- Supplier qualification (audits, evaluation, and development of suppliers within the quality management system)
-Technical file – compliant and aligned with all relevant standards and regulatory requirements
- Process consulting (implementation of quality management systems / process modeling, e.g., with ViFlow, Visio / KPI development and reporting)
- CAPA support (ISO 9001 / ISO 13485)
- Audit-ready implementation of a quality management system including a quality manual (ISO 9001 / ISO 13485)
- Support during external audits and regular system maintenance (ISO 9001 / ISO 13485)


  • QMR Compact

External Assumption of the QMR Function


  • Interim Management & Coaching

- Coaching of QMRs and Regulatory Managers
- Change management
- Short-term assumption of quality management functions


  • MDSAP

Audit Preparation & Support







 
 
 
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