Quality management - ISO 13485
Quality management
As a manufacturer of medical devices or IVDs, you need a quality management system in virtually every market. ISO 13485 is used worldwide for such systems in medical technology.
We are here to assist you with any questions you may have about ISO 13485!
We create QM systems in accordance with ISO 13485 – if required, we can also link these to other management systems.
We improve existing QM systems in terms of efficiency and effectiveness.
If there are any deviations, non-conformities or other problems in the QMS, we help you to resolve them.
Organizational project preparation
Software tools:
We use software to keep track of our projects. So, the first thing we do is set up a new project.
Software tools:
We record project efforts down to the second using software. Therefore, a new project is first created in the time tracking system.
Quality management:
As part of our quality management system, competent personnel are assigned to your project.
Operational project preparation
Project management:
Detailed planning of required project results
Project risk management:
Analysis of potential project risks with definition of measures
Customer communication:
Definition of suitable communication channels and contact persons
Quality management:
Obtaining necessary input information and documents
Project implementation
Quality management:
Internal kick-off meeting
Quality management:
Processing of the project in defined work packages
Quality management:
The results of the work packages are subject to internal quality control
External review
Customer communication:
Review of project results by our client
Quality management:
Improvement of project results, if necessary
Service release
Quality management:
Release of final project results
Customer communication:
Provision of final project results to our client
Project completion
Quality management:
Archiving of project results
Data protection:
Deletion of input documents and information
Software tools:
Archiving of the project in our project management tool
Software tools:
Archiving of the project in our time recording tool
If you have any questions or want to book a service, feel free to contact us!
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Why choose us?
Trust
Trust is one of our most important values. That is why we attach great importance to the security of your data and exchange them with you only via secure servers in Germany.
Customer satisfaction
Your satisfaction is our highest goal in all projects. A project is only successful for us if you are satisfied!
Reliability
Do you have to solve a critical issue at short notice? Together we can do this - if necessary, even with a night shift. Because we are always available for our customers.
