Défaut de validation pour ce fabricant de dispositifs médicaux
2. Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i).
a. Your firm uses “(b)(4)” and “(b)(4)” to take (b)(4) of patients’ teeth and determine the desired movement pattern to generate your dental aligners. Your firm has not validated this software, you use as part of your production activities, for its intended use.
b. Your firm uses “(b)(4)” and “(b)(4)” to convert (b)(4) of patients’ impressions to file types compatible with the (b)(4) used to manufacture the molds for your dental aligners. You have not validated these software programs for their intended use.
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