Your requirements
Our commitments
Your reliable partner for customized solutions in the medical technology and pharmaceutical industries.
Flexible
Adaptability to the individual needs of customers and changing requirements.
Communicative
Clear, open and transparent communication to ensure close collaboration with customers.
Team-oriented
Collaboration within the team and with customers to achieve success together.
Reliable
A dependable partner for our customers, consistently delivering high quality even under demanding conditions.
Our Services
We offer services in the areas of process development and validation, management systems and compliance, industrial building and infrastructure planning, as well as project procurement and supplier management.
We support companies both in operational tasks and in the structural development of their technical and organizational processes.
Insights into Our Projects
Implementation of an Energy Management System
for an International Medical Technology Company
For the German organization of a global medical technology company, we implemented an energy management system in accordance with ISO 50001. The project covered several production and administrative sites with different technical conditions and energy consumption structures.
A particular challenge was integrating the new system into existing management systems, including ISO 13485 and ISO 14001. The goal was to create a standardized, integrated management system that effectively connects regulatory requirements with internal processes.
In addition to the structural development of the system, the project included the analysis of significant energy consumers, coordination with technical departments, and the definition of cross-site processes within the project scope. Through close collaboration with the various departments, a system was established that can be continuously operated and further developed.
Implementation of a Multi-Stage Production Line
within an International Manufacturing Network
As part of a long-term global transfer project, we contributed to the implementation of a multi-stage production line at several international locations. The line consisted of multiple specialized systems forming a continuous production process. The objective was to transfer the established production standards of a reference site to additional countries and to establish a harmonized, cross-site production process.
Close coordination between the technical teams of the participating countries was a key component of the project. Different local conditions, equipment configurations, and organizational structures required detailed process analysis and precise alignment.
Due to the high product variety, validation of the production line posed particular challenges for process design. We were responsible for the technical development and optimization of the involved process steps, planned and executed the validation activities, and coordinated the results with the teams in the participating countries. This approach enabled the establishment of a consistent and reproducible production process.
Implementation of Digital Process Data Collection
in the Manufacturing of Highly Classified Medical Devices
In a regulated production environment where paper-based chart recorders had previously been used to capture critical environmental parameters, we supported the transition to fully digital data collection. The objective of the project was to reduce manual documentation steps, simplify evaluation processes, and enable faster responses to deviations.
The challenge was to further develop existing processes so that they meet the requirements for the manufacturing of Class III medical devices, including drug-coated products. This included analyzing the existing paper-based workflows, developing a digital data collection concept, and transferring records into a validatable data format.
Our responsibilities included the technical development of the new processes, the planning and execution of the required validation activities, and coordination with the relevant technical departments. Through digitalization, documentation effort, response times, and the traceability of production-related data were significantly improved.
Procurement on
Behalf of the Client
600
Technical Infrastructure Modifications
20
Qualification &
Validation
70
Supplier Evaluation &
Supplier Management
5
3D Scans &
As-Built Surveys
80
Implementation
of Management Systems
5
Technical Building and Infrastructure Drawings
400
Change
Management
510
Construction Planning &
Project Coordination
40
Development and Optimization of Production Processes
120