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Secure by Design
Medical Devices

Secure patient data and protect medical devices from cyberattacks
Medical Devices Industry
Book a Demo
Medical Devices Industry

Are your medical devices being designed with security in mind?

Medical devices, medical software, and healthcare infrastructure are targets for threat actors.

Product development frameworks must include security by design to safeguard patients.

Medical devices, medical software, and healthcare infrastructure are targets for threat actors. Product development frameworks must include security by design to safeguard patients.

Medical Devices Industry
Increases risk of cyberattack

Medical devices save lives; lacking a Secure Product Development Framework will have harmful ramifications for patients.

Medical Devices Industry
Hinder access to new markets

Post-October 2023, FDA demands more stringent cybersecurity scrutiny in medical device premarket submissions.

Medical Devices Industry
Scarce security resources

Product security teams are stretched thin, which can lead to marketed medical devices being vulnerable to cybersecurity threats.

Decrease risk of cyberattacks

Medical Devices Industry
SD Elements allows organizations to build medical devices using a Secure Product Development Framework (SPDF) to protect consumer health and sensitive customer data.
Medical Devices Industry
Medical Devices Industry

Grow revenue by demonstrating compliance

Medical Devices Industry
SD Elements allows organizations to enter new markets by demonstrating compliance with standards and regulations, such as HIPAA.

Scale Product Security

Medical Devices Industry
SD Elements provides developers with actionable security guidance delivered directly into existing development tools and workflows.
Medical Devices Industry

Compliance Regulations in SD Elements

  • HIPAA
  • MDS2-2013
  • ANSI/ISA 62443
  • AICPA Trust Services Criteria (SOC2)
  • ASD-STIG
  • Brazil Data Protection Law (LGPD)
  • California Consumer Privacy Act (CCPA)
  • California Online Privacy Protection Act
  • CIS Amazon EKS Benchmark
  • CIS AWS Foundations Benchmark
  • CIS AWS Three-Tier Web Architecture Benchmark
  • CIS Google Cloud Platform Foundation
  • CMMC 2
  • CNSSI
  • COPPA
  • CWE/SANS Top 25
  • CWE Top 25 2023
  • Cybersecurity Maturity Model Certification (CMMC)
  • DIACAP
  • EBA-Security of Internet Payments
  • EN 303 645 (Consumer IoT)
  • FedRAMP
  • GAPP
  • GDPR
  • GDPR: Agile Development Report
  • GLBA
  • ISASecure CSA 311
  • ISASecure SSA 311
  • ISO 27001
  • ISO/SAE 21434
  • NIST 800-53
  • NIST 800-82
  • NIST 800-171
  • NIST AI RMF
  • NIST Cybersecurity Framework (CSF)
  • NIST-EO-Critical-Software
  • NIST-EO-Software-Verification
  • NIST-SSDF
  • NY SHIELD
  • OWASP Top 10
  • OWASP IoT Attack Surface Areas
  • OWASP IoT Top 10
  • OWASP Top 10 Privacy Risks
  • OWASP Top 10 for Large Language Model Applications
  • PA-DSS
  • PCI-DSS
  • PIPEDA
Medical Devices Industry

Ensuring Cybersecurity in Medical Devices: A Guide to FDA’s Latest Guidelines

The medical device industry is evolving rapidly, with innovation and technology pushing the boundaries of what is possible in healthcare.
Read Blog

Additional Resources

Secure Your Medical Devices

Introduce a Secure Product Development Framework (SPDF) to develop your medical device with security
by design to meet new cybersecurity requirements from the FDA and other regulatory agencies.
Introduce a Secure Product Development Framework (SPDF) to develop your medical device with security by design to meet new cybersecurity requirements from the FDA and other regulatory agencies.
Book a Demo
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