Supporting the development of personalized medical devices and drug technologies

Scientific regulatory support

Based on many years of experience in medical device regulation, the High-Performance Center Medical and Pharmaceutical Engineering provides support in the scientific design and performance of conformity assessment and approval procedures for medical devices including in vitro diagnostics. The focus is on the design and implementation of regulatory strategies for conformity assessment and approval of conventional and novel medical devices and related product groups in the EU and beyond. In the area of regulatory affairs, research is focused on the issue of advancing the regulatory systems for better patient and health protection. Based on the ever increasing range of solutions and innovations in medical technology, regulatory requirements are critically scrutinized and further developed.

Benefits

  • Experienced experts in regulatory affairs/regulatory science
  • International expertise
  • Conformity assessment from multiple perspectives
  • Extensive product portfolio
  • Networking with industry and authorities

Advanced test methods

The High-Performance Center Medical and Pharmaceutical Engineering offers a wide range of state-of-the-art imaging systems that can be used to examine any object. We have access to a diversity of imaging systems for a wide range of applications, from microscopy, magnetic resonance imaging or magnetic particle imaging to investigate biological samples to computed tomography to visualize the internal structures of mechanical and electrical components. Our focus is on the development of customized test systems based on risk assessment and individual requirements. This includes, for instance, the determination of performance tests, investigations on influences of drug aerosols on respiratory circuits or long-term functional in-vivo testing of neurological and other electrophysiological implants.

Benefits

  • Customized test systems
  • Industrial computed tomography with sub-micrometer resolution
  • Medical and preclinical testing including imaging
 

Further information

Scientific development and manufacturing processes

Due to their small to very small batch sizes, patient- and application-specific medical devices and drugs strongly shift the relationship between development and production towards development. Therefore, economical solutions require new approaches to development processes. This is where the High-Performance Center comes in, to unleash the full potential of individualization provided by additive manufacturing with polymers and metals for medical technology. Various state-of-the-art 3D printing techniques are available for this purpose – from microscopically small and highly precise plastic objects to high-strength titanium implants.

Individualized drugs require innovative manufacturing processes. Here, too, the High-Performance Center draws on its expertise in production and process engineering. The aim is to combine existing single solutions for tailor-made surfaces for products and production systems.

Benefits

  • ISO certification according to DIN ISO 13485:2016
  • Technology transfer for the development of medical devices
 

Further information

Knowledge sharing and training

One of the key features of the High-Performance Center for Medical and Pharmaceutical Engineering is the targeted, partnership-based professional training, i.e. the transfer of knowledge and know-how based on technical objectives. Enhancing the expertise of project partners as well as cooperating on a scientific and technical level through targeted and continued training is a top priority here. With our focuses on

  • implants and additive manufacturing using medical-grade silicone, plastics and metals,
  • inhalation technologies for aerosol administration and patient-specific drug manufacturing, and
  • comprehensive scientific regulatory consulting services,

we cover most of the current hot topics in biomedical engineering.

Benefits

  • Progress through research
  • Systematic and targeted knowledge transfer into society
  • Translation of new technologies into applications and practical use
  • Transdisciplinarity

Standardization and norms

The experts of the High-Performance Center actively participate in the national and international standardization work in the fields of medical and drug technology. Focuses of the standardization efforts are, on the one hand, on development, implementation and assessment requirements for management systems in the context of medical device regulation, including the areas of quality, risk management, preclinical and clinical evaluation, post-market surveillance and maintenance management. On the other hand, technical requirements for innovative product areas are defined, further developed and brought to standardization. Based on a standardization roadmap, we offer expert support in standardization and rulemaking projects in all focus areas of the High-Performance Center.

Benefits

  • International expertise in standardization/norms
  • Creation of a standardization roadmap
  • Active participation in committees