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As a medical device does it meet all regulatory approvals?

April 26, 2017approvals device medical meet regulatory

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As a medical device does it meet all regulatory approvals?

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There are two elements of regulatory approvals. The first is that the device can be lawfully sold and meets these regulatory requirements. The second is if it is fit for purpose and meets the regulations regarding its claims for use. As an IVD Device, the Midstream has stringent regulatory requirements to meet in order to obtain its CE mark or FDA approval. The Midstream is CE marked and FDA approved and so we believe it can be sold we believe anywhere in the world subject to the local registration laws of selling a medical product. In regard to fit for purpose we believe this should be set out in a Technical Specification Sheet so that the purchaser can make an objective decision. Press here for the Technical Specification sheet for the Midstream.