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An EU based MD company is manufacturing condoms sold worldwide. The final packaging is performed in 2 adjacent production clean rooms of ISO 14644-1 Class 8 classification, however the company plans a reconstruction to join the 2 rooms into a single room of the same classification. The engineering department contact the company's regulatory professional in order to verify the regu;atory impact of this engineering change. Which action should the reg. professional take with respect to EU market?
a. Submit the change notification to the NB before implementation
b. Notify the NB of the change during the next surveillance audit
c. Submit the change notification to the local CA before implementation
d. Document the change in the company's QMS
Finance is about Gunns Ltd, a company in dealing with forestry products in Australia. The company has also been listed in Australian Stock Exchange. As many companies producing forestry products, even Gunns Ltd is facing various problems. Due to the ..
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