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If your medical device or software connects to the Internet, it’s vulnerable to external attacks. Cyber threats are real, and patient safety is a priority, so cybersecurity is no longer an option; it’s a requirement
How does D.Med Software approach cybersecurity in medical devices?
We provide IoT medical device security solutions that create a fully protected environment that meets the most rigorous standards, such as HIPAA, FDA, and MDR. We go beyond compliance by integrating healthcare IoT security into every phase of your product’s lifecycle, from design to post-market, keeping you ahead of emerging threats.
With a Zero Trust security architecture, every IoT device is continuously monitored, reducing the risk of unauthorized access and safeguarding patient data.
Trust us to keep your systems secure from evolving cyber threats.
Regulatory Consulting
Our mission is simple: to help you implement cybersecurity processes that are fully compliant with FDA (Premarket Cybersecurity Guidance, Section 524B) and MDR (MDCG 2019-16, NIS2) standards. Our team follows the IEC 81001-5-1 standard for healthcare software to ensure the highest levels of security throughout your product's lifecycle.
We understand that regulatory compliance can feel overwhelming, especially in the early stages of product development.
Our team is here to support you build a strong regulatory foundation so you can focus on building a secure and compliant device.
Early and effective engagement with the regulatory landscape is critical to a smooth regulatory process. We streamline the integration of cyber security processes into your QMS, proactively addressing potential regulatory issues before formal submission. We develop personalized regulatory strategies that streamline the process, reducing time to market and saving on costs.
QMS case study
Submitting a 510(k) can be complex, but our team simplifies it by guiding you through every step. Whether you're looking for hands-on assistance or a fast-tracked process, we have solutions tailored to your needs.
Ideal for teams that need support and expert review but want to manage most of the documentation themselves.
If you’re short on time, this service guarantees quick results. We combine regulatory and software expertise to expedite your submission process, cutting months off your timeline.
Risk Assessments
We use Threat Modelling to identify potential threats and build defenses against them. We also perform continuous Security Risk Analysis at each stage of development, enabling real-time adjustments.
Integrate seamlessly into your secure software development lifecycle (SSDLC) without disrupting production. This eliminates the need for last-minute fixes, which in turn removes the potential for additional costs. Essential to avoid delays and costly fixes later. How can we help here:
We analyze your software to identify vulnerabilities and security gaps.
We prioritize risks based on potential impact so you know where to focus.
We provide actionable solutions to fix or minimize vulnerabilities, ensuring your software is secure and compliant.
Development
As part of our services, we offer expert guidance in security medical controls from a software development perspective. These controls act as mitigation strategies for specific vulnerabilities or threats, particularly for companies that may lack the technical expertise or resources to address them.
Typical security medical control implementations include:
Our services focus on identifying vulnerabilities, implementing security controls, and continuously monitoring potential risks to comply with FDA/MDR regulations.
Verification Activities: We ensure traceability and robust security testing. We conduct unit and integration testing using a Traceability Matrix to verify that every security control is implemented and tested effectively. Our full traceability action plan guarantees no missed requirements, securing your device and meeting healthcare security standards.
Pentesting
Simulates cyberattacks to find vulnerabilities before they're exploited, which is critical for IoT healthcare security due to patient safety risks.
Scope
Our plan is to use a combination of white and grey box methods to provide comprehensive coverage of potential vulnerabilities.
Execution
Our experts rigorously test systems, focusing on sensitive data and critical functions.
Reporting
We provide detailed reports prioritizing risks based on severity.
Mitigation
A tailored plan is created to address the identified vulnerabilities.
FAQs
Our team thoroughly analyzes your Development Life Cycle to identify any weaknesses in cybersecurity that could lead to future vulnerabilities. We review and assess your current Standard Operating Procedures (SOPs) and workflows to ensure all phases, from design to maintenance, are covered. We incorporate crucial cybersecurity steps and conduct a risk assessment for each development phase.
We ensure that cybersecurity best practices are woven into the DNA of your development process, preventing costly fixes later on.
We define clear roles for your team in cybersecurity management. Our continuous risk assessment also ensures that new vulnerabilities are swiftly identified and handled as the project evolves.
Our team will guide you in developing the required documents and processes crucial for MDR and FDA compliance. We help document cybersecurity architecture and conduct thorough threat analysis. We also ensure that risk management practices are consistently followed and documented.