medical device traffic sign on blue sky

medical device traffic sign blue sky device regulatory compliance quality assurance product development manufacturing process risk assessment safety standards performance testing prototype design approval innovation user interface biocompatibility sterilization methods packaging labeling requirements clinical evaluation post-market surveillance management control usability materials selection design verification validation submissions classification facility registration traceability system recall adverse events instructions use liability maintenance servicing supplier trials shelf life tracking compliance audit market lifecycle conformity history file investigations risk-benefit analysis claims authority