Technology, data and quality management

The fields of medical engineering and biotechnology are characterized by short innovation cycles. In order to optimally shape the product development process and market launch, the Fraunhofer IPT develops quality and risk management systems, which are tailored to these specific industries, and also advises companies on technical matters by means of market studies and process analysis.

The requirements relating to products and manufacturing processes are particularly high in the life sciences sector. Our response is to develop and optimize customized quality and risk management systems for companies in the medical engineering and biotechnology sector, which help them to bring products safely and efficiently to market. The integrated application of established and newly developed quality management methods – from the product development stage to product utilization - is a vital element for certification of compliance with ISO 13485/14971 or cGMP. The Fraunhofer IPT can help you to design these management systems in accordance with the applicable standards and will ensure that you meet all statutory and regulatory requirements.

Machines, production lines and systems already provide large volumes of data. It is essential to condense, analyze and interpret this information in order to acquire the knowledge needed for implementation of improvements and increased efficiency. However efforts in this direction are often thwarted by heterogeneous IT-infrastructures, non-compatible formats and local data storage devices. The Fraunhofer IPT can help you to identify and exploit appropriate systems, processes and algorithms to enable you to access the wealth of knowledge contained within your data.

Strategy is the DNA of a company. An expertly crafted technology strategy is vital to the successful development and launch of new technologies, be it in the medical engineering, food or pharmaceutical sector. We therefore accompany our partners – from the original concept of their technology management through to helping to shape the contents of the strategies, processes and methods. Future deployment of technologies and products in the life-sciences sector, for example, can be planned with the aid of rigorous, methodologically supported technology road-mapping processes. In such cases, we conduct trend analyses in order to determine specific customer and market requirements relating to certain technologies and products for life-sciences applications.

We work with our clients to plan the launch of the technology on the market. Additionally, we provide technology and competence-based diversification by highlighting how expertise and technologies can be used to tap into new markets or to expand existing markets meaningfully. We evaluate the appeal of diversification for companies, thereby creating a sound decision making basis.