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
