TISSUE SERVICES

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.

• BMSI works with clients to conform to ISO 22442, parts 1, 2 and 3 & FDA guidance documents.
• We perform risk assessments, write SOPs, and develop protocols and systems.

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.

• We will develop strategies to perform the viral inactivation & TSE / BSE elimination studies.
• Coordinate and conduct studies.