Small Medical Device Manufacturer (<200 employees)
Company Stage: Two hardware products launched; working on their first digital health product (SaMD)
CHALLENGES
Client had no experience with mobile or cloud software; relied 100% on development partner
Software development partner had no experience with medical devices and regulations; they were making undocumented and uncontrolled changes to the software late in development
Clinical testing was scheduled to begin soon and the project needed to be brought quickly into compliance
SOLUTION
Focused initially on software configuration controls and software change controls. Through frequent meetings with the client and their development partner, was able to quickly establish control processes and documentation for the product software
Replaced the client’s software development SOP with a procedure better able to support digital health products
Created cybersecurity SOP for client
Assisted product team with guidance and templates through multiple software releases to complete all necessary software and cybersecurity documentation
RESULTS
Client was able to proceed with clinical study and subsequent FDA submission and received approval for their first digital health product
