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Friday, May 04, 2012 2:17:36 PM
DD on CE timeline and Expert Resource:
How much does it cost to obtain ISO 13485 certification?
To assist in that process, we have attempted to give you a very broad yet realistic sense of your estimated investment in obtaining ISO 13485 certification. In general, a smaller to mid sized company with one location that is not manufacturing high risk devices can expect to spend about US$30,000-$45,000 - looks like the stock sales were to pay for consulting fees.. which is not a bad thing at all.
From Expert Resource: ER's approach to ISO Management Systems consulting is very comprehensive, flexible, and affordable. Our consultants maintain a 100% success rate of attaining registration upon first attempt. ER also offers a compliance guarantee! Expert Resource guarantees that your documentation prepared by ER will pass the final audit, regardless of which registrar you choose to audit your management system. Beware of consultants who only guarantee based on the registrar they choose for you.
ER?s clients take only 6 months or less to registration. This means that your organization will realize benefits quickly. In some cases, we have been as fast as 4 months. Seeing that Phase 1 is done.. I would think we are somewhere closer to 3 months or less...
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