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📢 Webinar: The Future of Application Security | May 22nd, 2024

🔥 Upcoming Webinar: The ROI for Security by Design – March 26th | 2pm EST

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Webinar: The Future of Application Security
May 22nd, 2024 Save your spot now

Secure by Design
Medical Devices

Secure patient data and protect medical devices from cyberattacks

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.

Increases risk of cyberattack

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

Hinder access to new markets

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

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

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

Grow revenue by demonstrating compliance

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

Scale Product Security

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

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

CMMCS2
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

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.

Additional resources

How ChatGPT Will Affect Application Security

Read Blog >

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.

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