BMSI is intimately familiar with Commission Directive 2003/32/EC (TSE) and ISO 22442 for regulatory compliance.
We procure bovine and porcine tissue for use in heart valve leaflets
The standards require that companies conduct disease monitoring on an on-going basis, evaluate the risks of the disease outbreaks and document it periodically. We will manage these activities for our clients.
We consult, develop strategies, coordinate testing and studies, write protocols and reports, and handle unforeseen complications that may arise.
BMSI deeply understands the needs of animal derived tissue products and knows how important it is to properly fix (cross-link) the tissue. We help clients develop and implement a process for tissue fixation.
We also offer complete support for transcatheter heart valves development starting from tissue procurement to valve production
We develop SOPs and implement in-house tissue traceability systems.
We offer end to end anti-calcification treatment: From design to formulation & transfer.