2023 Sponsors and Exhibitors
CeCert
CeCert is a dynamically developing certification and notified body offering its services in certification: management systems, medical devices, training, supplier audits. In 2019, we were entered on the list of authorized ERCA partners in the field of audit training, and from 2020 we have been accredited by the Polish Center for Accreditation for the QMS PN-EN ISO 9001: 2015-10 and MDMS PN-EN ISO 13485: 2016-04 programs . In October 2021, the Minister of Health authorized CeCert in the field of in-vitro diagnostic medical devices and appointed it as a notified body. On January 3, 2022, we were assigned the number of a notified body - 2934. We are currently trying to obtain notification in the scope of Regulation 2017/745 regarding medical devices.
DevGoMed
DevGoMed was created utilizing cooperation of experienced specialists in the field of design, research and implementation into clinical practice of innovative biomaterials and advanced medical devices, including implants.
A wide range of assistance in the medical technologies development, DevGoMed relies on experts’ many years experience in:
• planning and supervising the medical technology development
• risk management of a medical device along its life cycle
• managing R&D projects
• preclinical and clinical evaluation of medical devices
• implementing a quality management system for the production of a medical device in accordance with ISO 13485
• preparation of technical documentation of products to obtain the CE mark
• post-market surveillance of medical devices
Polbionica
Polbionica is a biotech company established by the Foundation on Research and Development of Science to commercialise 3D bionic pancreas research and thinks boldly about the future. The application of the bionic pancreas in clinical practice will revolutionise the treatment of diabetes and become one of the greatest medical successes of the 21st century. Concerning the growing number of patients with type I diabetes and the limitations of available treatments, functional 3D bioprinting is a viable option to overcome the problem of organ shortage and will also reduce the number of complications associated with surgery and the use of long-term immunosuppression after transplantation.
In late 2020, we completed the preclinical phase of 3D bionic pancreas research; we are developing very promising results and we are also preparing for the clinical phase. While working on the 3D bionic pancreas bioprinting project, we created proprietary products crucial for the 3D bioprinting development. These include customised bio inks, a bioreactor, and innovative bioprinting methods.
Foundation of Cardiac Surgery Development in Zabrze (FRK)
Foundation of Cardiac Surgery Development in Zabrze (FRK) was set up in 1991 in order to introduce the latest methods and techniques of rescuing human life into clinical practice, to support cardiac surgery and related fields, and to support health protection and promotion activities.
The Foundation’s activities are focused primarily on conducting and financing research, innovation, and implementation works for the treatment of heart diseases, especially in the area of medical, pharmaceutical, biological, mathematical and physical, chemical, and technical sciences; on the enhancement of medical and nursing staff; on the activity in the field of scientific information concerning cardiology and cardiac surgery; on running heart diseases treatment databanks; on training, information, educational and publishing activity; on technology transfer initiatives.
The Foundation’s activity is in conformity with the Quality Management System as per ISO 9001:2015 in terms of research and implementation works, and training activity. The Medical Device Manufacturing Plant is a certified manufacturer of elements of heart prostheses. acc. to ISO 13485.
The Heart Prosthesis Institute, as a sub-cell of the Foundation of Cardiac Surgery Development, is responsible for R&D work, especially for mechanical heart support and biocompatibility tests. The research area also includes planning and performing in-vitro and in-vivo biological biocompatibility tests of raw materials, biomaterials, and medical devices in the scope of the PN EN ISO 10993 standard. We adjust the test profile and the method of their implementation individually to the research, organizational, and financial needs of the client. We provide substantive support in the preparation of applications and grants and prepare applications to the National Ethics Committee.
Areas of our experience and activities:
• Chemical testing of biomaterials as a phase of biocompatibility and risk assessment of a medical device.
• Hemocompatibility and thrombogenicity tests.
• In-vitro cytotoxicity studies.
• Biocompatibility tests in-vivo on small animal models - rabbits, guinea pigs.
• Functional/preclinical studies on large animal models – pigs, sheep, calves.
• Preparation of medical device documentation and support for risk management of the development of a medical device.