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In preserving alone independent from your HS, ISO 13485’s clause composition, Regardless of currently being depending on ISO 9001, serves to satisfy the exceptional requires from the health-related system sector. The choice not to fully harmonize the normal Along with the structure seen in Annex SL most likely stems from the necessity to make cer
The accountable human being should ensure compliance Along with the related obligations established out inside the regulation.The obligation of appointing an EU REPRESENTATIVE isn't going to use to situations exactly where the legislator anticipates a little threat from the privacy perspective. This can be the scenario if processing only will take
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