K
kiwi.kczt
Hi Covers, I've been struggling to find a right answer for this question.
We are manufacturing a Class IIa non-sterile device. The device is made up of approximately 6 components, out of which 2 are patient-contacting. To make the complete device, these components are assembled with medical UV-cure adhesive. The cured adhesive would not come in direct contact with the patient.
For biocompatibility testing, do we send in the patient-contacting components in the final finished form (injection and compression molded), or do we send the assembled device, from which the test lab would remove the required components for testing?
Thanks in advance!
Keith
We are manufacturing a Class IIa non-sterile device. The device is made up of approximately 6 components, out of which 2 are patient-contacting. To make the complete device, these components are assembled with medical UV-cure adhesive. The cured adhesive would not come in direct contact with the patient.
For biocompatibility testing, do we send in the patient-contacting components in the final finished form (injection and compression molded), or do we send the assembled device, from which the test lab would remove the required components for testing?
Thanks in advance!
Keith