In today’s digital age, cybersecurity is a critical concern for medical device manufacturers. At confinis, we provide expert guidance on implementing robust cybersecurity measures to protect your devices and data from cyber threats. Our services include risk assessments, vulnerability analyses, and the development of comprehensive cybersecurity plans.
We help clients understand and comply with regulatory requirements related to cybersecurity, such as the FDA’s cybersecurity guidelines and the EU’s MDR. Our team provides practical advice on designing secure systems, implementing encryption and authentication measures, and conducting regular security audits. By enhancing your cybersecurity posture, you can protect patient data, ensure device integrity, and maintain regulatory compliance.
Regulatory Compliance Consulting
Ensure your medical device meets all necessary cybersecurity requirements with our comprehensive regulatory compliance consulting services.
Offered Packages/Services
| Assessment of Product Cybersecurity Scope: We evaluate whether your product falls within the scope of cybersecurity regulations. | Assessment of Product Cybersecurity Scope: We evaluate whether your product falls within the scope of cybersecurity regulations. |
| Regulatory Requirement Information: Receive detailed information on current regulatory requirements for your target market. | Compliance Gap Analysis: Conduct gap analyses to identify and address deficiencies in cybersecurity practices and regulatory compliance. |
Who is this service for?
This service is ideal for medical device manufacturers, healthcare technology developers, and compliance officers looking to navigate and meet regulatory cybersecurity standards.
Contact us to learn more about how we can help you achieve regulatory compliance for your medical devices.
Cybersecurity Documentation
Develop robust documentation to ensure comprehensive cybersecurity measures are in place for your medical devices.
Offered Packages/Services
| Cybersecurity Management Plan: Create detailed plans that outline cybersecurity strategies and responsibilities. | Cybersecurity SOPs (Standard Operating Procedures): Develop standard operating procedures for all cybersecurity processes. |
| Incident Response Plan: Design effective incident response plans to manage and mitigate cybersecurity incidents. | Secure SDLC Practices: Review your SDLC documentation to ensure cybersecurity is integrated from design to deployment. |
Who is this service for?
This service is ideal for medical device manufacturers, software developers, and IT security professionals who need to establish or enhance their cybersecurity documentation.
Contact us to learn more about how our documentation services can strengthen your cybersecurity posture.
Security Risk Management
Identify and mitigate potential security threats to your medical devices with our comprehensive risk management services.
Offered Packages/Services
| Security Risk Assessment: Identify and evaluate potential security threats to your medical device or healthcare product. Analyze vulnerabilities, assess risks, and receive actionable recommendations to enhance your security posture by conducting thorough threat modelling. |
Who is this service for?
This service is perfect for medical device manufacturers, healthcare product developers, and IT security teams seeking to ensure regulatory compliance and safeguard patient data.
Contact us to learn more about how our security risk management services can protect your medical devices from potential threats.
Security Verification and Validation (V&V)
Ensure your medical devices and healthcare products meet stringent security standards with our verification and validation services.
Offered Packages/Services
| Security Requirements Testing: Verify that your software meets security requirements and handles error scenarios. | Threat Mitigation Testing: Test the effectiveness of threat mitigations. Ensure mitigations work as designed and do not introduce new vulnerabilities. |
| Vulnerability Testing: Identify and characterize potential security vulnerabilities. Includes abuse case testing, attack surface testing, and known vulnerability scanning. Software composition analysis and dynamic security testing. | |
| Penetration Testing: Identify weaknesses by discovering and exploiting security vulnerabilities. | Conflict of Interest Management: Ensure objectivity in testing efforts across various security assessments. |
Who is this service for?
This service is ideal for medical device manufacturers, healthcare product developers, and quality assurance teams aiming to verify and validate the security of their products.
Contact us to learn more about how our security V&V services can ensure the security and compliance of your medical devices.
Software Bill of Materials (SBOM) Management
Ensure transparency and compliance of all software components in your medical devices with our SBOM management services.
Offered Packages/Services
| SBOM Creation and Maintenance: We guide you in developing and maintaining detailed SBOMs according to IMDRF guidelines. This includes: 1. Collecting SBOM Content 2. Generating SBOM 3. Distributing SBOM 4. Maintaining SBOM Content |
Who is this service for?
Perfect for medical device manufacturers and software developers needing to track and document all software components for regulatory compliance, healthcare providers aiming to enhance cybersecurity transparency, and regulators assessing device security.
Contact us to learn more about how our SBOM management services can enhance the transparency and security of your medical devices.
Vulnerability Management
Proactively manage and mitigate security vulnerabilities in your medical devices with our continuous monitoring and remediation services.
Offered Packages/Services
| Continuous Monitoring and Remediation: Implement ongoing processes to identify, monitor, and remediate vulnerabilities throughout the product lifecycle. This includes: 1. Real-Time Monitoring 2. Vulnerability Assessment 3. Remediation Plans 4. Reporting and Documentation |
Who is this service for?
Ideal for medical device manufacturers, healthcare technology developers, and IT security teams looking to maintain a high level of cybersecurity and ensure ongoing compliance with regulatory standards.
Contact us to learn more about how our vulnerability management services can safeguard your medical devices against emerging threats.
Training and Education
Equip your teams with the knowledge and skills needed to ensure cybersecurity and regulatory compliance for medical devices.
Offered Packages/Services
| Best Practices: The latest cybersecurity best practices to protect your products. | Regulatory Requirements: Detailed guidance on meeting regulatory requirements in the US and EU markets. |
| Post Market Surveillance Activities Related to Cybersecurity: Training on monitoring and managing cybersecurity risks post-market, ensuring ongoing compliance and security throughout the product lifecycle. | |
Who is this service for?
Perfect for medical device manufacturers, software developers, compliance officers, and IT security teams seeking to enhance their knowledge and capabilities in medical device cybersecurity.
Contact us to learn more about how our training and education programs can empower your teams to ensure the security and compliance of your medical devices.
