Medical Device Cybersecurity

Protect Your Medical Device From Cybersecurity Risks

Cybersecurity vulnerabilities can put your device, patients, and market access at risk. Get expert support to identify threats, strengthen security, and build the evidence needed to meet regulatory expectations.

Build a Stronger Cybersecurity Foundation

Identify cybersecurity hazards, vulnerabilities, and risks that could affect your device, users, or data.

Threat Modeling

Understand potential attack paths, threat scenarios, assets, and security risks specific to your device and its environment.

Define appropriate security requirements and controls and integrate them into your device design and software architecture.

Evaluate your implemented security controls and identify vulnerabilities that need to be addressed before market entry.

Prepare the cybersecurity evidence and documentation needed to support regulatory submissions.

Monitor emerging vulnerabilities, assess their impact, and manage cybersecurity risks throughout the device lifecycle.

Medical device engineer reviewing cybersecurity protection and vulnerabilities

Reduce Cybersecurity Risk Before It Becomes a Bigger Problem

Cybersecurity issues are easier to address when they are identified early. Build security into your device development and reduce risks that could affect patients, regulatory approval, or market access.

Identify Vulnerabilities Earlier

Discover security weaknesses and potential attack paths before they become harder and more expensive to address.

Protect Your Device & Users

Implement appropriate security controls to protect device functionality, sensitive data, and users from cybersecurity threats.

Reduce Regulatory & Post-Market Risk

Build stronger cybersecurity evidence and prepare your team to manage vulnerabilities throughout the device lifecycle.

A Clear Path to Stronger Device Cybersecurity

Build security into your development process with a structured approach that helps your team understand threats, address risks, and demonstrate cybersecurity readiness.

1. Understand Your Device & Threats

Review your device, software, connectivity, data flows, use environment, and potential cybersecurity threats.

2. Assess & Address Security Risks

Identify vulnerabilities, evaluate their potential impact, and implement appropriate security controls to reduce risk.

3. Demonstrate & Maintain Security

Test your security controls, prepare the required cybersecurity evidence, and establish ongoing monitoring for new vulnerabilities.

Cybersecurity Expertise Built for Medical Devices

Medical device cybersecurity connects software, risk management, patient safety, and regulatory compliance. Get specialized support that helps your team address security without losing sight of your device’s regulatory requirements.

Medical Device Cybersecurity Expertise

Work with specialists who understand the cybersecurity challenges and expectations specific to connected and software-driven medical devices.

Risk-Based Security Approach

Focus cybersecurity activities on the threats and vulnerabilities that could create meaningful risks for your device and users.

Regulatory & Technical Support

Connect technical cybersecurity activities with the evidence and documentation expected for regulatory submissions.

Lifecycle Cybersecurity Support

Manage cybersecurity beyond market entry with vulnerability monitoring, assessment, remediation, and ongoing security activities.

Protect Your Device Beyond Market Launch