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.
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!
