We’re excited to announce the launch of our new cybersecurity services tailored to meet the regulatory requirements of medical devices. With cybersecurity threats increasing, ensuring your medical devices are secure and compliant is crucial. Our services are designed to support you in this critical area.

Here’s a closer look at what we offer.

Our Regulatory Compliance Consulting services ensure your medical devices meet all necessary cybersecurity requirements.

We offer:

Assessment of Product Cybersecurity Scope: We help you determine if your product falls under specific cybersecurity regulations.

Regulatory Requirement Information: We provide comprehensive details on the current regulatory requirements for your market.

Regulatory Strategy Support: We offer assistance in crafting a regulatory strategy to achieve cybersecurity compliance.

Compliance Gap Analysis: Identify and address gaps in your existing cybersecurity practices.

Robust documentation is key to effective cybersecurity.

Our services include:

Cybersecurity Management Plan: Develop detailed plans outlining your cybersecurity strategies and responsibilities.

Cybersecurity SOPs (Standard Operating Procedures): Establish standard procedures for all cybersecurity processes.

Incident Response Plan: Design plans to effectively manage and mitigate cybersecurity incidents.

Secure SDLC Practices: Review your SDLC documentation to ensure cybersecurity is integrated from design to deployment.

Our Security Risk Management services help you identify and mitigate potential security threats to your medical devices:

Security Risk Assessment: Identify and evaluate potential security threats, analyze vulnerabilities, assess risks, and provide actionable recommendations to enhance your security posture.

Ensure your medical devices meet stringent security standards with our verification and validation services:

Security Requirements Testing: Verify that your software meets security requirements and handles error scenarios.

Threat Mitigation Testing: Test the effectiveness of threat mitigations to ensure they work as designed and do not introduce new vulnerabilities.

Vulnerability Testing: Identify and characterize potential security vulnerabilities through various testing methods.

Penetration Testing: Discover and exploit security vulnerabilities to identify weaknesses.

Maintain transparency and compliance with our SBOM management services:

SBOM Creation and Maintenance: Develop and maintain detailed SBOMs according to IMDRF guidelines, collect content from various sources, and keep SBOMs updated to reflect changes.

Proactively manage and mitigate security vulnerabilities in your medical devices with our continuous monitoring and remediation services:

Continuous Monitoring and Remediation: Implement ongoing processes to identify, monitor, and remediate vulnerabilities, ensuring minimal disruption and maintaining compliance.

Equip your teams with the knowledge and skills needed for cybersecurity and regulatory compliance:

Cybersecurity Training Programs: Offer comprehensive training tailored for development and compliance teams, covering best practices, regulatory requirements, and post-market surveillance activities related to cybersecurity.

Our cybersecurity services are ideal for medical device manufacturers, healthcare technology developers, software developers, IT security professionals, compliance officers, and quality assurance teams. Whether you need to establish robust cybersecurity measures, meet regulatory compliance, or enhance your team’s expertise, we’ve got you covered.

Stay ahead of cybersecurity threats and ensure compliance with our comprehensive services.

Contact us today to learn more about how we can support you in achieving your cybersecurity goals.