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Software Remediation

CriTech is an acknowledged industry expert at helping medical device companies remediate gaps in their software Design History File (DHF) and/or Technical File (TF). We have successfully remediated more than 100 products with challenged software files.

Our services include reverse engineering of requirements and complete verification and validation of designs. Our diverse skill sets and techniques combined with our knowledge of required processes and tools allow us to execute remediation projects in the most efficient manner.

Each of our remediation efforts received subsequent approval from the FDA and/or EU Notified Body. We give you the best chance to bring your product's Design History File or Technical File up to standard effectively and without worry.

Over 100 remediation efforts completed – all submissions received subsequent approval from the FDA and/or EU.