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Most likely. Even if you intend to outsource ALL production, the FDA along with other businesses will maintain you chargeable for items you area that you can buy. If an incident happens with your product, the regulatory authorities aren't going to examine your subcontractor, they can inspect your Corporation as the lawful entity for advertising the device.
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Quickly trace CAPAs the many way back again in your style and design controls so your personnel can deal with accelerating your small business.
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