BioMeld

The BioMeld project aims to develop a biohybrid catheter system that integrates muscle-actuated biohybrid machines (BHMs) for medical applications. This innovative system involves various aspects, including the design and manufacturing of the catheter structure, integration of 3D bioprinted skeletal muscle, flexible electronic platforms, and control software. The project also focuses on simulation feedback loops to improve the catheter's performance, uncertainty analysis, and the establishment of a bio-intelligent manufacturing cell (BIMC).

The standardisation objectives of the BioMeld project involve ensuring that the developed biohybrid catheter system meets established quality and regulatory standards. This includes adhering to relevant standards in the domains of materials, manufacturing processes, medical devices and trustworthy AI. 

Reason for applying to HSbooster.eu services

The BioMeld project recognizes the importance of standardisation in (i) ensuring the quality, safety, and regulatory compliance of its biohybrid catheter system and (ii) the use of AI in designing medical devices.
We need expert guidance in the following key areas:

a) Understanding standardisation basics on fundamental concepts, terminology, and processes related to standardisation;
b) Choosing appropriate types of standardisation by analysing the project's objectives, technological scope, and regulatory landscape;
c) Insights into various standardisation bodies and help in identifying the most relevant organisations to engage with;
d) Assistance in identifying gaps in existing standards that are pertinent to the biohybrid catheter domain, helping to pinpoint areas where new standards may be needed.
e) Support the project team in conducting comprehensive searches for relevant standards, evaluating their applicability, and selecting those that best meet the project's requirements.
f) Clarifying the interplay between standards and regulations so we can better navigate compliance requirements and ensurealignment with applicable regulations governing medical devices and biotechnology.