Quality and Regulatory Affairs



Developing products and manufacturing processes for medical products is a highly-technical and extremely complex business that is controlled by a strictly-regulated environment and influenced by rising costs. To be cost-effective, it is important to get things right first time round. Fraunhofer IPA has many years of experience in applying quality methods in a wide range of industries. It means a lot to us to transfer the methods that we have implemented and adapted successfully in these industries to other sectors. We know a lot about the pharmaceutical and medical industries and about the challenges of specific method application. We have gained this know-how not only from the numerous industrial projects we have been involved in but also through applying methods within the scope of our own research and development projects. We support our customers in the following areas:

Targeted derivation of product specifications

Using a methodic approach based on quality function deployment (QFD), customer requirements (e.g. QTP – quality target profile) can be systematically incorporated in technical specifications (CQA – critical quality attributes) in the early stages of product development. The method offers good possibilities for taking usability requirements (see also EN 62366: Medical devices – Application of usability engineering to medical devices) into account right from the start, and therefore for systematically fulfilling CE label requirements.

Technical risk assessment in product and process development

Based on a product’s critical quality features, the concept of “quality by design (QbD)” serves to systematically derive critical product attributes (CMA – critical material attributes) and subsequently derive process characteristics (CPP – critical process parameters). The application of modern FMEA methods is an effective and efficient way of achieving this. With over 25 years of experience in applying these methods, we assist numerous companies with the technical risk assessment of products and production processes and also help them systematically derive production control plans. If aspects concerning automation, technical cleanliness and cleanliness validation are involved, we can also obtain additional expert knowledge from other departments at Fraunhofer IPA.

Risk assessment according to DIN EN 14971

Application risks as well as technical risks connected with products and production processes may result in dangerous situations for third parties. A targeted risk assessment method, which ideally is linked with technical risk analyses in the product development process, ensures that CE label requirements are met (see DIN EN 14971).

Ensuring the compliance of product materials/processes with RoHS and REACH

In addition to this, we also help companies implement processes for the management of hazardous substances and integrate them into IT infrastructures.