Extra Security helps medical device manufacturers get through FDA cybersecurity review — faster, cleaner, and without surprises.   
                                                                                                                                     
We do two things exceptionally well: penetration testing and threat modeling for connected medical devices. Your device ships to our hardware lab, where our team tests network protocols, firmware, physical interfaces, and cloud components the way a real attacker would. You get back a report mapped to FDA premarket cybersecurity guidance, ready to drop into your 510(k) or PMA submission.                                                                                                                        
                                                                                                                                     
  Every engagement includes:                                                                                                         
  - 4-week turnaround from device receipt to final report
  - FDA-compliant deliverables (executive summary, methodology, findings with proof-of-concept, risk assessment, remediation roadmap)
  - One free re-test within 60 days                                                                                                  
  - Transparent, upfront pricing — no scoping games                                                                                  
                                                                                                                                     
We also help manufacturers respond to FDA ANIN cybersecurity letters, validate equivalency claims for substantial-equivalence submissions, and build custom engagements for unusual devices or testing scopes.                                                   
                                                                    

Extra Security

Org chart

Teams

Offices

Extra Security

Org chart

Teams

Offices

Related companies