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Greeting Everyone:
I am wondering how are medical device manufactures performing design validation for implants, in this case a class 2 device Vertebral Body Replacement device (intended for use in the thoracolumbar spine (T1-L5). Device has been tested to the required performance standards (design verification). FDA has approved 510K (As substantially equivalent) But I am unsure how to do design validation. Clinical or animal studies are not cost effective and have significant timeline constraints, I cannot find any computer simulation software program available. Any recommendations or comments you might have will be greatly appreciated.
I am wondering how are medical device manufactures performing design validation for implants, in this case a class 2 device Vertebral Body Replacement device (intended for use in the thoracolumbar spine (T1-L5). Device has been tested to the required performance standards (design verification). FDA has approved 510K (As substantially equivalent) But I am unsure how to do design validation. Clinical or animal studies are not cost effective and have significant timeline constraints, I cannot find any computer simulation software program available. Any recommendations or comments you might have will be greatly appreciated.