Outlines an approach for verifying/validating the design and manufacture of a transcatheter heart
valve substitute through risk management. The selection of appropriate verification/validation tests
and methods are to be derived from the risk assessment. The tests may include those to assess
the physical, chemical, biological and mechanical properties of heart valve substitutes and of their
materials and components. The tests can also include those for preclinical in vivo evaluation and
clinical evaluation of the finished heart valve substitute.