Our goal was to develop a process management tool where medical device manufacturers would have the greatest possible degree of freedom to model their business processes to adapt to MDR and ISO regulatory requirements, thus ensuring business continuity from a regulatory perspective.
Reference: 2017/745 of the European Parliament (EP) and the European Council (EiT). regulation on medical devices, and the requirements of EN ISO 13483:2016.
European Union standards harmonized according to the MDR on the basis of the Annex to Executive Regulation (EU) 2021/1182:
We train your company’s production processes,
and not the one we have devised.
Secure access.
You can control who can see or change your data.
CUSTOMIZED TO YOUR NEEDS!
An important element of the introduction of the CTMed system is the consulting service. This activity of ours ensures that the system works exactly according to your needs without compromise, in accordance with the regulatory requirements.
OUR CONSULTING SERVICES include:
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- Joint process analysis and planning with our customers
- Mapping of logistics and production processes
- Customization of forms, measurement records, and reports
- Migration of existing data – if necessary
- System integration
- Implementation, installation
- Initial assistance
- Education
- System support
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FEATURES
Process and resource optimization
- Setting deadlines for individual tasks
- No more slips, no more delays
- Easy handling, simple follow-up
- Increasing resource utilization
Documentation
It has a special role in the MDR requirements
- Related data and information in one central place
- Easily and quickly transparent
- Management of technical and quality assurance documentation, monitoring of its life path
- Management of internal and external documents produced within the system
- The document retention period
- Support for clear retrievability by searching for previously closed processes and their steps.
- Management of accompanying materials related to delivery (label, packaging, instructions for use, warranty letters, implant companions).
Support for reporting
- Production of reports required by the MDR
- Support of quality assurance audits
- Graphs and charts
- Continuous availability of task lists
Follow-up of production and quality assurance procedures
- Production preparation
- Production management
- Clear management of operational steps
- Documentation of quality assurance operations, external (e.g. laboratory test data sheets) documentation
- Production of production documentation
Support for logistics tasks
- Management of the process from order to delivery
- Management of shipping documents
- Inventory management: raw materials, semi-finished products, finished products and scrap
- Registration of master data
CAPA management support
- Record of deviation cases
- Management of deviation cases (from detection to actual outcome)
Code and record systems
- Provision of requirements for UDI systems
- Management of batch and factory numbers
Traceability
- All information is up-to-date in one system
- Management of parallel projects
- Possibility of project controlling
Integration options
- Google G Suite and MS Office compatibility
- Mobile version (option)
- Interfaces to existing systems (option)Google G Suite és MS Office kompatibilitás
OTHER FIELDS OF APPLICATION
Management of Solar power station installation projects
From application to operation
Renewable energies, including subsidised solar power generation, are playing an inc-reasingly important role. Participants in the solar sector have to simultaneously meet a number of market and regulatory requirements, serve their customers and ensure long-term stability for their own companies.
We can help you with our CellTracker solution!
Our solution helps you manage and monitor solar power projects from the initial land search to the implementation of your solar power project by customising the CellTracker system to the specific needs of your business.
Main project development phases:
- Project design and planning
o Searching for potential land, investigating
o Preparing the connection to the DSO
o Contract management
o Planning permission management
o Managing the METÁR application
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- Task management of solar power plant operation
Telecommunications
Roll-out support, worldwide to more customers
CellTracker provides effective support for the deployment and management of more than one million base stations worldwide.
Functional groups (modules) are:
Software modules coordinate and manage the roll-out process from site acquisition through radio planning to customer support.
- Radio planning management from the initial planning phase to the launch of a new site, from the initial planning to the implementation of the radio site
- Site acquisition
- Investment management
- Data transmission planning
- Telecommunications implementation and integration
- Fault ticket management
- Project management