MedDeV
Cyber Security

Cyber Security: Protecting Medical Devices

MedDev Soft provides a comprehensive cyber security framework for medical devices, assessing threats and vulnerabilities to ensure patient safety and device integrity. Our meticulous cyber security plan and reporting system adhere to FDA, MDR, and NIST guidelines, along with ISO 27000 series standards for information security management systems (ISMS).

Cyber Security Highlights

Device Risk Analysis
Evaluating the potential impact of cyber threats on device functionality and patient safety.

Threat Modeling and Vulnerability Assessment
Determining the likelihood of threats and assessing the device’s vulnerability to security breaches.

Risk Level Determination
Classifying cyber security risks of medical devices and understanding various mitigation strategies.

Cyber Security Management Strategy
Establishing a robust management approach that identifies assets, threats, and scrutinizes corner cases.

MedDev Soft is dedicated to fortifying the cyber security of medical devices, ensuring they meet global regulatory standards and protect against the evolving landscape of cyber threats.

Secure your medical devices against cyber threats with MedDev Soft. Contact us to implement a robust cyber security strategy.

Cyber Security in Detail

Cyber Security Plan and Report

Developing detailed cyber security plan and report which meet regulatory standards.

FDA and MDR Compliance

Ensuring cyber security measures comply with FDA guidance and the Medical Device Regulation (MDR) of the European Union.

NIST Alignment

Aligning with the National Institute of Standards and Technology (NIST) framework for cyber security.

ISMS Implementation

Implementing ISMS according to the ISO 27000 family of standards for systematic information management.

SBOM Management

Effective management of the Software Bill of Materials (SBOM) for tracking and mitigating cyber security risks.

HIPAA and GDPR

Ensuring compliance with HIPAA and GDPR for patient privacy and data protection.

Global Regulatory Privacy

Adhering to privacy requirements for global markets, ensuring comprehensive cyber security coverage.

Threat Modeling

Systematically identifying and assessing potential security risks and vulnerabilities to ensure the development and deployment of robust and secure healthcare technologies.

Secure Development Lifecycle

Integrating security practices throughout the entire process, aiming to identify and mitigate potential vulnerabilities and threats from the initial design phase to the deployment of the final product.

Cyber Risk Analysis

Conducting thorough cyber risk analysis to inform security strategies and mitigate potential threats.

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Software Quality
Assurance (SQA)
Software Verification and
Validation (V&V)
Software
Development
Cyber Security
Risk
Management
Consulting &
Training Services
Regulatory Compliance
(MDR/FDA)
Implementation and management of compliance

with ISO standards