I have recently joined this forum and hope to be in compliance with the forum guidelines. I am a medical device manufacturer and I would like to have from you if possible an idea of how much a complete set of biocompatibility tests could cost. For chemical characterization for example, the price will fluctuate a lot according to the type of device, my request concerns, in particular, the LAL test.
However, in my opinion, it would be very useful to have feedback from those who have already met the requirements of 10993. It could help me a lot to decide my strategy for the future.
Of course, the cost will depend a lot on the categorization of the product based on duration and type of contact, the device with which I have to deal is let's say the worst in terms of endpoint having a long term contact with tissues and even blood.
If anyone would like to share their experience based on cost or other info it would be very helpful for me.
However, in my opinion, it would be very useful to have feedback from those who have already met the requirements of 10993. It could help me a lot to decide my strategy for the future.
Of course, the cost will depend a lot on the categorization of the product based on duration and type of contact, the device with which I have to deal is let's say the worst in terms of endpoint having a long term contact with tissues and even blood.
If anyone would like to share their experience based on cost or other info it would be very helpful for me.