How a Global Medical Technology Leader Secured FDA QSR Compliance and Embedded Security by Design with Opsfolio CaaS

The Company

A Global Leader in Infection Prevention and Device Management

The client is a longstanding global leader in medical device safety and infection prevention workflows, serving hospitals and healthcare providers in more than 100 countries. With over four decades of innovation and ISO 13485–certified quality systems, the organization has become a trusted partner to healthcare facilities and equipment manufacturers worldwide. Its portfolio spans automated disinfection systems, device tracking platforms, and storage solutions, all designed to help providers meet stringent regulatory standards and protect patients from infection.

The Opsfolio team worked with the client to secure a device management platform that integrates real-time data on equipment use, disinfection cycles, and firmware updates. This platform is critical for ensuring that semi-critical medical devices are consistently safe, compliant, and ready for patient care.

Because the organization operates at the intersection of patient safety, device innovation, and regulatory compliance, its reputation depends on software and systems that are both reliable and demonstrably compliant with the FDA’s Quality System Regulation (QSR). A lapse could trigger FDA enforcement actions, jeopardize contracts with hospitals, and weaken the brand’s position in the global healthcare ecosystem.

The Challenge

Meeting QSR Standards While Securing Mission-Critical APIs

The client’s device management platform relied on APIs to deliver compliance-critical data and connect seamlessly with hospital systems. As the platform scaled, so did the pressure to ensure its security, reliability, and regulatory alignment.

• API Functionality: Accuracy and seamless integration across 10 API endpoints were essential. If data was incorrect or failed to flow properly, hospitals risked losing visibility into device readiness, disrupting care, and triggering compliance concerns.
• Security Risks: Penetration testing identified vulnerabilities including SQL injection, XSS, and authentication flaws. If exploited, these could expose sensitive data, create FDA compliance failures, and erode trust with healthcare partners.
• Integration Needs: The APIs had to interoperate flawlessly with the latest generation of the client’s platform. Integration breakdowns would have risked downtime, inaccurate reporting, and compromised infection prevention protocols.
• Regulatory Compliance: Compliance needed to be proven not only against FDA QSR but also related standards such as ISO 14971, SSL/TLS encryption, and healthcare data security practices. Falling short would have invited regulatory findings, costly remediation, and competitive disadvantages.

These challenges represented not just technical issues but business-critical risks to regulatory standing, customer contracts, and the organization’s reputation for safety and reliability.

The Solution

Embedding Security and Compliance Into the Development Lifecycle

To overcome these risks, the client partnered with the Opsfolio CaaS team, adopting a security-first compliance approach that made regulatory evidence a natural byproduct of development rather than an afterthought.

Opsfolio integrated security and compliance into the Secure Development Lifecycle (SDL) from day one. Threat modeling and compliance mapping were built directly into engineering workflows, ensuring that regulatory artifacts were created automatically as software was developed. Instead of scrambling for documentation before an audit, the client could demonstrate continuous compliance at every stage.

The platform was engineered with security by design. Opsfolio guided the team in adopting secure coding practices, conducting architectural reviews, and performing penetration testing throughout development. This gave hospitals and auditors concrete proof that the system wasn’t just compliant on paper but was fundamentally secure in its design.

A rigorous program of verification and validation (V&V) proved both that the software was built correctly (verification) and that it met the right requirements (validation). Formal verification methods and systematic testing were combined with customer-driven validation, such as user acceptance tests, performance benchmarking, and security validation based on how hospitals and regulators actually interacted with the system.

To strengthen this, Opsfolio executed an in-depth API testing campaign covering functional, security, integration, regression, and compliance testing. Key activities included validating accurate data handling and edge cases, confirming seamless interoperability with new system generations, verifying authentication and blocking vulnerabilities, stress-testing performance after updates, and confirming adherence to ISO 14971 and healthcare encryption standards. By leveraging Microsoft Playwright for automation, Jira and Xray for tracking, and Tailscale for secure testing, the team ensured a thorough and repeatable process. This gave the client confidence that its platform could run securely while meeting both regulatory requirements and the operational expectations of hospital partners.

All of this work was captured through Opsfolio’s centralized evidence hub, which logged results, security checks, and validation evidence mapped directly to FDA QSR and related standards. Auditors received a transparent, traceable record of compliance without pulling staff away from core operations.

Finally, continuous monitoring with Surveillr kept the asset fleet under real-time watch, detecting vulnerabilities before they could disrupt service. This proactive stance helped maintain uninterrupted hospital workflows and eliminated the costs of reactive remediation.

The Results

Regulatory Confidence and Market Trust

The partnership with Opsfolio delivered not just an audit win, but a stronger market position built on demonstrable security and compliance:

• Regulatory Alignment Secured: FDA QSR and ISO 14971 compliance confirmed, protecting certifications and preserving contracts tied to regulatory approval.
• Risk Reduced: Security by design and proactive monitoring lowered the likelihood of vulnerabilities disrupting operations or triggering enforcement.
• Trust Strengthened: Hospitals and partners saw verifiable proof of secure design, reinforcing long-term confidence in the brand.
• Efficiency Improved: Compliance artifacts were generated automatically through development, reducing administrative overhead and freeing staff to focus on innovation.

By shifting compliance from a checkbox exercise to a proof of secure design, Opsfolio enabled the client to align regulatory requirements with business growth, strengthening its standing as a trusted global partner in infection prevention and device management.

The Future

Continuous Compliance as a Competitive Advantage

After working with Opsfolio CaaS, the client now treats compliance as an always-on capability, not a point-in-time scramble. This transformation positions the organization to bring its solutions into new markets, adopt AI-driven technologies, and meet evolving global standards without compromising security or compliance.

By turning compliance into a strategic differentiator, Opsfolio has helped the client build not only audit readiness but also a secure development culture that ensures lasting trust with hospitals, regulators, and patients worldwide.