Validation for your production process
For the development of the required process, we focus on close cooperation with our customers. In joint steps we develop, optimize and complete the manufacturing process through all validation phases, parallel to product development. In requirements for later series production, we supervise each individual process step in order to guarantee our customers a smooth, high-quality and ultimately certifiable production line.
Individual support
- In collaboration with the customer, the critical processes are defined. On this basis, the scope of testing is determined and a validation tailored to the customer is offered.
In-house cleanrooms
- In addition to intensive support in workshops and meetings, our customers also find ideal conditions in our premises. Our own clean rooms are provided at our state-of-the-art production plant.
Pre-qualification
- To enable a smooth start of production, a pre-qualification can take place at our premises. Ideal test conditions are available in our modern laboratory.
Key to efficiency and safety
In the world of mechanical engineering, technical documentation is not just a formal act, but an essential part of the entire product life cycle. It serves as an indispensable source of information for engineers, operators, users and maintenance personnel.
Technical documentation comprises a large number of documents that provide information on the design, function, operation, service and maintenance of machines.
- Construction drawings and CAD models
- Operating and maintenance manuals
- CE declarations of conformity and risk assessments
- Assembly instructions and spare parts list
Precise and clear to avoid misunderstandings
Comply with legal requirements and standards
Structured and well maintained, for easy updating
CE-compliant in national language, especially for international markets
While the basics of technical documentation are universal, there are specific requirements in medical technology and precision engineering. These include the highest safety standards, comprehensive risk assessments and strict regulatory documentation in accordance with the MDR (Medical Device Regulation). Within precision engineering, there are particularly detailed specifications for precision components, which are often supplemented by detailed images in the µ range and exact dimension tables.
At the beginning of the project kickoff, the client defines all requirements together with the project manager in a user requirements specification (URS). On this basis, IMSTec creates a functional specification (FS = Functional Specifications), which specifies the scope and implementation of the project. IMSTec acts according to the following guidelines:
- Medical Device Regulation (ISO 15378)
- GMP-Guidelines (Good Manufacturing Practices)
- Quality management standard (ISO 9001)
Technical documentation is much more than a collection of instructions. It makes a decisive contribution to safety, efficiency and legal compliance. Particularly in specialized sectors such as medical technology, the pharmaceutical industry and precision engineering, detailed, precise and standard-compliant documentation is essential.
- Training for users and maintenance personnel
- Customer-specific documentation solutions
- Fast updates and digital access to technical documentation
As digitalization progresses, it is not only the formats and processes that are changing, but also the requirements for modern and digital documentation. For example, instructions and maintenance instructions can be accessed via electronic documentation platforms.
Digital technical documentation is far more than just a replacement for paper documents. It offers new opportunities to increase efficiency and improve user-friendliness. However, regulatory requirements must always be complied with and sensitive data must be protected from unauthorized access.
How can we help you?
Get in touch with us.