Medcrypt PMA Remediation Success: Overcoming Major Cybersecurity Deficiencies for Cardiac Device

At a Glance

• Client: Cardiac device manufacturer
• Challenge: Major PMA cybersecurity deficiencies threatening approval
• Solution: Embedded expertise & targeted remediation strategy
• Impact: Increased PMA approval confidence without over-engineering

Challenge

• Major cybersecurity deficiencies during PMA review
• Threatened approval and market launch
• Required immediate remediation without long development cycles
• Options: hire expensive full-time security staff or pursue costly over-engineered solutions

Details

A cardiac device manufacturer received devastating news during PMA review: major cybersecurity deficiencies that threatened approval and market launch. The deficiencies spanned documentation gaps, software vulnerabilities, and insufficient security management processes—issues requiring immediate remediation without the luxury of long development cycles. The manufacturer faced a critical decision: hire expensive full-time security staff (adding permanent overhead), pursue costly over-engineered solutions (risking usability and COGS increases), or find expert guidance to address deficiencies efficiently while maintaining device performance and regulatory timeline.

At a Glance

Medcrypt embedded cybersecurity expertise directly into the manufacturer's team, providing on-demand guidance without the cost burden of permanent staff additions.

• Embedded cybersecurity expertise directly into manufacturer's team
• On-demand guidance without cost burden of permanent staff
• Former FDA reviewers ensuring focus on regulatory priorities
• Focused on regulatory priorities rather than theoretical security ideals
• Balanced compliance with practical business constraints

Embedded Cybersecurity Expertise

Medcrypt embedded cybersecurity expertise directly into the manufacturer's team, providing on-demand guidance without the cost burden of permanent staff additions. The collaborative approach combined documentation improvements, targeted software updates, and new security process adoption—each remediation carefully scoped to address FDA concerns without introducing unnecessary complexity.

Targeted Remediation Strategy

Medcrypt's former FDA reviewers ensured remediation efforts focused on regulatory priorities rather than theoretical security ideals, preventing over-engineering that could harm usability or increase manufacturing costs. The tailored remediation plan balanced compliance requirements with practical business constraints.

Medcrypt's embedded approach delivered systematic remediation that addressed FDA priorities while maintaining practical business constraints and device performance.

• Increased PMA approval confidence through systematic remediation of all identified cybersecurity deficiencies with guidance from former FDA reviewers who understood agency priorities
• Reduced cost burdens by embedding Medcrypt expertise on-demand rather than hiring permanent full-time security staff, providing flexibility as needs evolved
• Prevented over-engineering risks that could have compromised device usability, increased cost of goods sold, or delayed time-to-market through unnecessary complexity