• Test & Certify

    Securing Tomorrow, Today: Your Pathway to Comprehensive IoT Solutions, Independent Assessments, and Global Compliance.

  • MDR | Cybersecurity in Medical Devices

    Embark on a journey through the labyrinth of the Medical Device Regulation (MDR). This crucial regulation is a cornerstone in ensuring the safety and effectiveness of medical devices within the European Union. It's a tapestry woven with stringent requirements and detailed compliance standards, all designed to uphold the highest quality in healthcare technology. Let's decode the complexities of MDR and chart your path to compliance!

  • What We Offer

    Securing Your Connected World: Tailored Services for Robust Cybersecurity

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    Gap Analysis

    • Thorough examination of existing systems, processes, and documentation to identify compliance gaps with respect to MDR requirements.
    • Detailed reports outlining identified gaps, potential risks, and providing a roadmap for remediation.
    • Providing practical recommendations to address identified gaps and achieve MDR compliance.

     

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    Security by Design

    • Integrating security measures right from the design phase of medical device development to ensure robust protection.
    • Designing a secure architecture that complies with MDR requirements and best practices in cybersecurity.
    • Regular security testing and validation throughout the development lifecycle to ensure ongoing compliance and security.
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    Certification Support

    • Assistance in preparing all necessary documentation required for MDR certification in a structured and organized manner.
    • Conducting mock audits and pentration testing to ensure readiness for MDR certification.
    • Providing support in liaising with notification bodies and supporting you up to getting certified.

  • Our Approach

    1

    Consultation and Gap Analysis

    • Initial consultation to understand the client's current medical device regulatory compliance status, systems, and processes.
    • Conducting a gap analysis to identify areas of improvement towards MDR compliance.
    • Providing actionable recommendations and a roadmap for achieving MDR certification readiness.

     

    2

    Technical and Procedural Implementation Support

    • Assistance in the implementation of recommended measures, including technical solutions and procedural changes.
    • Support in developing and documenting the required policies, procedures, and system changes to meet MDR requirements.
    • Guidance on the creation of necessary technical documentation as per MDR specifications.

     

    3

    Preparation & Review

    • Conducting mock MDR audits to measure progress and prepare the organization for the actual certification process.
    • Offering feedback and further recommendations for improvement to ensure the organization is well-prepared for MDR certification.
    • Streamline the certification process through our CyberPass platform.

     

    4

    Continuous Improvement and Compliance Maintenance

    • Providing ongoing support for maintaining and improving MDR compliance measures.
    • Assistance in monitoring and adapting to evolving MDR requirements and regulatory changes.
    • Engaging in regular reviews and updates to ensure continued compliance and readiness for periodic MDR audits.

  • Potential Delivrables  

     

    📃 Security Assessment Report

    A comprehensive document that details the findings of a thorough security assessment conducted in line with MDR requirements. This report
    identifies potential security risks, evaluates the effectiveness of current security measures, and provides recommendations to bolster the security posture of the medical devices and associated systems.

     

    📊 Comprehensive Reports

    A step-by-step manual tailored to your organization, outlining the procedures and best practices for implementing security controls based on MDR standards. Identify potential vulnerabilities and areas of improvement in the security landscape, ensuring fortified defenses.

    📚 Certification Documentation and Mark

    A well-organized compilation of all necessary documentation required for MDR certification based on the MDCG guidance. This includes policy documents, procedure manuals,
    and evidence of compliance. The documentation aims to reflect a strong commitment to adhering to MDR standards, showcasing a mark of excellence in regulatory compliance readiness.

  • Why Choose Red Alert Labs ?

     

    Expertise

    Helped in designing and testing multiple medical device products for big players in the healthcare industry. We've been also participating to several initiative accross the EU addressing the cybersecurity of medical devices (e.g. https://www.entrust-he.eu/). Influencing on the MDCG and relevant applicable standards (e.g. IEC 62443, UL 2900, EN 303645, ...).

    One-Stop Solution

    From initial consultation and gap analysis, through 'Security by Design' implementation, to certification support, we provide a comprehensive suite of services tailored to meet all your MDR compliance needs. Our holistic approach eliminates the need to engage multiple service providers, ensuring a seamless, coordinated path to compliance.

    Customized Approach

    We understand that every organization has unique challenges and requirements. Our services are meticulously tailored to meet the specific needs of each client, ensuring a personalized, effective approach to achieving MDR compliance. Our commitment to understanding and addressing your unique compliance needs sets us apart in delivering value and fostering long-term partnerships.

    Speed & Scalability

    Our CyberPass platform makes the compliance process fast and scalable.

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