A medical device company identifies a new automated testing technology that could significantly reduce product verification time and improve accuracy. Within the context of their ISO 13485 management system, how should this primarily be addressed according to Clause 6.1?
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A
As a nonconformity, because it deviates from the current validated process.
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B
As an opportunity to be evaluated and potentially pursued to enhance the QMS.
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C
As a threat to be mitigated, due to the cost of implementation.
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D
As a corrective action to fix a known deficiency in testing speed.