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510K Notifications |
Auditing |
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510K NOTIFICATIONS
FDA's clearance letter is required before any manufacturer can market/sell a medical device in US market (unless the device is exempt). Many of FDA regulated devices fall under the medium risk (usually class 2), requiring 510k clearance letter PRIOR to marketing the product in US. We also provide Software Validation services as part of 510k submission.
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Key benefits:
Other than being able to legally market the device in US, the 510k clearance letter may be used as a marketing tool for countries other than the US. You will also get the extra assurance from FDA scientists who will review and clear the product. Your product design will be verified for safety and effectiveness and cross-checked against actual hospitals complaints as per FDA available databases generated by hundreds of FDA field investigators as well as European reporting through the MRA (Mutual Recognition Agreement).
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Mansour Consulting LLC - US FDA and European medical device regulatory consultants Phone: 678-908-8180, Fax: 678-623-3765, info@mansourconsulting.com |
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