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TISSUE SERVICES

BMSI is intimately familiar with Commission Directive 2003/32/EC (TSE) and ISO 22442 for regulatory compliance.

Following are our TISSUES services for the HEART VALVE industry:

Tissue Procurement

We procure bovine and porcine tissue for use in heart valve leaflets

Disease monitoring

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.

Tissue fixation

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.

iso 22442 fda compliance

  • 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.

End to end support

We also offer complete support for transcatheter heart valves development starting from tissue procurement to valve production

tissue traceability

We develop SOPs and implement in-house tissue traceability systems.

Anti-calcification

We offer end to end anti-calcification treatment: From design to formulation & transfer.

viral inactivation and tse/bse elimination studies

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