Documentation and government compliance such as 510 medical devices. The untold secret too this, this i simply a paperwork headache from beginning to end of an engineering project. We strongly suggest working with legal council that specialize in this field for purpose of making sure that all the specific details are met. Also, many times they can suggest added qualification that ones devices can or easily could meet for purposes of expanding the qualification and thus marketability of the device. Where we come in is in 2 parts.  The first is engineering documentation and review.  The second is business administration system creation for purpose of the long term and detailed document and facility tracking required. We can greatly reduce costs and increase inter activeness by providing these services and thus allowing the customer to lessen their need for legal council.

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