Cybersecurity
Regulatory
Secure Your Medical Devices and Streamline Regulatory Approvals with QDS’s Cybersecurity Expertise
In the highly regulated field of medical devices, ensuring robust cybersecurity is essential not only for patient safety but also for regulatory compliance. Qualified Data Systems (QDS) offers specialized Cybersecurity Services designed to support regulatory submissions, audits, and remediation efforts for Software in Medical Devices (SiMD), Software as a Medical Device (SaMD), and Multiple Function Device Products. Our services are tailored to help medical device manufacturers navigate the complex regulatory landscape, mitigate cybersecurity risks, and achieve successful product approvals.
Core Services
Cybersecurity Support for Regulatory Submissions
- Cybersecurity Documentation Preparation: QDS assists in the preparation of detailed cybersecurity documentation required for regulatory submissions, including cybersecurity risk management plans, security architecture descriptions, and threat modeling reports. Our documentation aligns with the latest guidance from regulatory bodies such as the FDA, EMA, and other international regulators.
- Risk Management File Development: We help develop and maintain comprehensive risk management files that document all identified cybersecurity risks, mitigation strategies, and residual risks. This file is crucial for demonstrating compliance with standards such as ISO 14971 and IEC 62304.
- Regulatory Guidance Alignment: Our experts ensure that your cybersecurity strategy and documentation meet the specific requirements of the relevant regulatory bodies. This includes adherence to FDA premarket cybersecurity guidance, EU MDR cybersecurity requirements, and other applicable regulations.
- Pre-Submission Consulting: QDS provides consulting services to prepare for pre-submission meetings with regulatory bodies. We help articulate your cybersecurity strategy, address potential concerns, and ensure that your submission is well-positioned for approval.
Cybersecurity Audit Support
- Audit Preparation and Readiness Assessments: QDS offers comprehensive audit preparation services, including mock audits and inspection readiness assessments. We identify potential gaps in your cybersecurity practices and provide actionable recommendations to address them before the official audit.
- Audit Response and Remediation: In the event of audit findings, QDS supports your organization in responding effectively to regulatory inquiries. We assist in developing and implementing remediation plans to address identified issues, ensuring that your products meet the necessary cybersecurity standards.
- Compliance Audits: We conduct internal compliance audits to assess your adherence to relevant cybersecurity regulations and standards. Our audits are designed to identify weaknesses, assess the effectiveness of your cybersecurity controls, and provide a roadmap for continuous improvement.
- Post-Audit Support: After the audit, QDS provides ongoing support to help maintain compliance and address any additional requirements or follow-up actions identified by the auditors.
Cybersecurity Remediation Services
- Vulnerability Assessment and Mitigation: QDS conducts in-depth vulnerability assessments to identify and prioritize security weaknesses in your SiMD, SaMD, and Multiple Function Device Products. We then provide expert guidance on mitigating these vulnerabilities, ensuring that your products are secure and compliant.
- Patch Management and Security Updates: We assist in the development and deployment of patch management strategies, ensuring that your products remain secure against known vulnerabilities. Our services include testing patches for potential impacts on product performance and regulatory compliance.
- Incident Response and Containment: In the event of a cybersecurity incident, QDS offers rapid response services to contain the threat, minimize damage, and restore normal operations. We also assist in documenting the incident and response actions for regulatory reporting purposes.
- Security Control Implementation: QDS helps implement and enhance security controls within your products and processes. This includes the deployment of encryption, access controls, intrusion detection systems, and other critical security measures to protect your products from cyber threats.
Industry Focus
QDS specializes in providing cybersecurity services for the following areas:
- Software in Medical Devices (SiMD): Ensuring that embedded software in medical devices meets regulatory cybersecurity requirements and is resilient against cyber threats.
- Software as a Medical Device (SaMD): Protecting standalone software applications that perform medical functions, ensuring they are secure, compliant, and ready for regulatory approval.
- Multiple Function Device Products: Addressing the unique cybersecurity challenges of products that combine medical and non-medical software functions, ensuring that all components meet regulatory standards.
Value Proposition
QDS’s Cybersecurity Services offer the following benefits:
By ensuring that your cybersecurity practices and documentation align with regulatory requirements, we help facilitate smoother and faster regulatory approvals for your SiMD, SaMD, and Multiple Function Device Products.
Our audit preparation and response services ensure that your organization is fully prepared for regulatory audits, reducing the risk of findings and ensuring a positive audit outcome.
We provide comprehensive remediation services to address cybersecurity vulnerabilities and audit findings, helping you maintain compliance and protect your products from evolving cyber threats.
QDS offers ongoing support to help your organization stay compliant with the latest cybersecurity regulations and standards, ensuring that your products remain secure throughout their lifecycle.