7749 Normandy Blvd.
Jacksonville, FL 32221
Compliance with the Design Control requirements in 21 CFR 820.30 and the product realization requirements in ISO 13485 can present a challenge. Often records are lacking and sometimes non-existent. The Design History File is confusing at best and worst yet, you may find yourself drowning in voluminous amounts of design control documents and none of them seem to link.
We can help. Let us use our proven method of creating design control deliverables which are simple, compliant and traceable. We specialize in Design History File content creation and remediation. Contact us today to see how we can help with your Design Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Risk Management, Design Transfer, Design Change and the Design History File.
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MD & PC Mission Statement:
Delivering compliant, audit ready quality system documents and solutions that support new product introductions, regulatory submissions and global quality system requirements for the medical device and pharmaceutical industries