Software Remediation

Identify and remediate gaps in software Design History Files (DHFs) and Technical Files (TFs) with complete requirements traceability

Software Remediation Services

  • Our services include reverse engineering of requirements and complete verification of designs.
  • We have successfully remediated more than 100 products with challenged software Design History Files or Technical Files.
  • Each of our remediation efforts received first-time approval from the FDA and/or CE Marking Notified Body.
  • 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.
  • We give you the best chance to bring your product's Design History File or Technical File up to standard effectively and without worry.
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We look forward to talking with you!

We are ready to assist in getting your medical device software compliant and can start at any point during your life cycle process!

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