Medtech device companies face significant challenges navigating stringent regulations such as MDR, FDA, and ISO 13485, alongside escalating cybersecurity risks. Traditional manual compliance and security processes consume extensive resources and pose constant operational risks. AI-driven compliance for MedTech offers transformative improvements through automated regulatory compliance, proactively identifying compliance gaps, and continuously monitoring cybersecurity threats.
This white paper illustrates how NovaCare Devices, a fictional medtech firm, partnered with Bridge Global to implement AI solutions, resulting in streamlined regulatory processes, faster audit readiness, enhanced cybersecurity, and substantial cost and time savings—empowering the company to innovate effectively while maintaining compliance and security excellence.
of compliance costs go to manual processes.
of a device's revenue can go toward compliance.
of hospital-connected devices face cybersecurity risks.
Manual processes slow patient care and create bottlenecks. See how AI can automate and streamline healthcare operations for better outcomes.
Disjointed communication leads to delays in critical care decisions. Explore how AI supports faster, better planning.
Healthcare software demands more than speed. See how our team balances safety, privacy, and compliance without cutting corners.