Regulatory science for biomaterials: are we doing right things right? Abstract

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Michael Gasik
https://orcid.org/0000-0002-5782-7987

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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How to Cite
Gasik, M. . (2024). Regulatory science for biomaterials: are we doing right things right? Abstract. HEMIJSKA INDUSTRIJA (Chemical Industry), 78(1S), 32. Retrieved from https://www.ache-pub.org.rs/index.php/HemInd/article/view/1275
Section
Biomaterials for orthopedic and dental applications

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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

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