Results our clients can point to
A record of outcomes achieved for our clients — across US FDA, EU MDR, and other markets, from first-time submissions to deficiency responses and major redesigns.
Deficiencies closed in quick time
A wearable device manufacturer received cybersecurity deficiencies on its EU MDR submission. Aktriva was engaged to review the existing documentation and bring it up to notified body expectations. We updated existing documents and prepared new ones to meet MDCG requirements, and the deficiencies were closed without any additional questions.
510(k) cleared, no FDA questions
Aktriva was engaged to review and update all cybersecurity documentation for a new-generation device, aligning it with current FDA standards and eSTAR requirements. Device received 510(k) clearance with zero questions from FDA.
Cleared without additional questions, in record time
After the manufacturer received an FDA deficiency letter, Aktriva was engaged to redraft the submission documentation and create new supporting reports to meet FDA expectations. The resubmission cleared without additional questions, in record time.
PMA approved, no cybersecurity deficiencies raised
A class III medical device with mobile and cloud connectivity underwent a major redesign shortly after Section 524B of the FD&C Act took effect. The complete cybersecurity submission package required for PMA approval, including security testing, was prepared across two submissions.
Every strong outcome starts with a conversation.
Each engagement here began with a discussion about where the device was in its lifecycle. Tell us where yours is.