Regulatory science for biomaterials: are we doing right things right? Abstract
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Abstract
The aim of this work is to highlight gaps and drawbacks in modern development of biomaterials which are intended themselves alone or in combination to be deployed in medical devices, especially for Class III under the EU MDR 2017/745. More tight requirements for biomaterials safety and efficacy demand proper testing and assessment which might be not always aligned with the R&D process.
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Funding data
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Horizon 2020 Framework Programme
Grant numbers 760921;952033
References
Gasik M. Understanding biomaterial-tissue interface quality: combined in vitro evaluation. Sci. Techn. Adv. Mater. (2017), 18:550-562. https://doi.org/10.1080%2F14686996.2017.1348872
Zuhlke A. Dynamic mechanical characterization of biomaterials for medical devices. Aalto University Doctoral Theses (2023), 148 p. https://urn.fi/URN:ISBN:978-952-64-1255-9
Gasik M. Biomechanical characterization of engineered tissues and implants for tissue/organ replacement applications. In: Biomaterials for Organ and Tissue Regeneration, Eds. E.N. Vrana, H. Knopf-Marques, J. Barthes, Woodhead Publ. (2020), 599-627. https://shop.elsevier.com/books/biomaterials-for-organ-and-tissue-regeneration/vrana/978-0-08-102906-0