Customer Case Study
Essenvia Saves Medtech Companies up to
19 weeks per 510(k) Submission
INDUSTRY
Healthcare
COUNTRY
US
COMPANY TYPE
Enterprise
Company Size
1000+
Background
The C has a bold objective to dramatically increase their FDA 510(k) submissions and clearances in 2024 while maintaining status quo with existing regulatory affairs resources and headcount. Submissions will increase sixfold from two 510(k) clearances in prior years to 12 submissions in 2024 (including two PreSubmissions) – five which are complex SaMD submissions
Challenges
The team received deficiency letter on prior submissions which were managed by the previous regulatory team. They needed to sift through pre-submissions, SIRs previous files, in order to properly reuse content and information to complete responses and subsequent submissions. All of this documentation was distributed, unorganized and used inconsistent templates. In essence, it had a high complexity publishing requirements. The team had to ensure the completeness and accuracy of all of the information it had at its disposal.
Results
Essenvia delivered value on day one, allowing the regulatory team to structure previously unstructured information into a master data library in the Essenvia platform. All files were loaded into Essenvia’s file vault which…