Our development services for your medtech product start with consultation on standards and legal regulations and guide you through all phases of development: from development planning and risk management to certification of the finished product. Special attention is paid to the documentation of the development according to the legal requirements. In other words, a tailor-made, standards-compliant customized contract development.
DEVELOPMENT
- Mechanical design and generation of drawings with SolidWorks
- Electrical design and layout as service
PROTOTYPE CONSTRUCTION
- Sample construction
- Assembly and commissioning of assemblies and complete devices
- Construction of testing equipment and assembly assistance
SMALL BATCH SERIES MANUFACTURING WITH QUALITY MANAGEMENT SYSTEM ACCORDING TO EN ISO 13485
- Lot size from one unit
- Flexible and customer-oriented solutions
- Pilot series
- Serial production
- Detailed traceability
COMPILATION OF THE TECHNICAL DOCUMENTATION
- Transfer of the development file into the technical documentation
- Consulting and preparation of risk management files in cooperation with the customer
- Consulting and preparation of the clinical evaluation
RESEARCH PROJECTS
- BioKat is in regular scientific exchange with Prof. Dr. Gunter M. Rothe (Professor Emeritus of Biology at the University of Mainz). He is still engaged in the research on the importance of electromagnetic fields in living systems
- Measurements and analyses of the transmission of subtle fields with Bioenergetic Information Therapy with Dr. Klaus Volkamer (Frankenthal)
- Experimental research of new agricultural techniques based on bioactive fields. Cooperation with the University of Applied Sciences Geisenheim, Center for Applied Biology – Institute Phytomedicine (Prof. Dr. Beate Berkelmann-Löhnertz and Dipl. Ing. Stefan Klärner)