3/9/2024 0 Comments Iso 13485 sop documentsOften, these kinds of requirements take the form of the ISO 13485 standard for medical device manufacturers. At some point soon, the current internal systems will not be able to hold back the deluge, and companies will be faced with a stark decision-consistently improve or perish” – Erik Myhrberg and Joseph Raciti, Practical Field Guide for ISO 13485 “On a global scale, we are all being asked to do more with less-and for less. That’s just the tip of the iceberg more severe penalties extend to include government bodies compelling you to dissolve your company, and ultimately the endangerment of the lives and well-being of individuals your organization is servicing. Failure to comply with several licencing regulations issued by the California Department of Insurance landed them a $7million fine. However, the struggle to turn a profit pales in comparison to some of the harsher consequences of failing to comply with certain regulatory requirements. In today’s business world, owners are constantly grappling with concerns and surmounting obstacles, the least of which is actually staying afloat financially in what can be an unforgiving economy.
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