Cybersecurity Solutions
Securing the Future of Medical Devices with Expert Cybersecurity Solutions
Cybersecurity is a critical concern for medical device manufacturers due to rising regulatory scrutiny and cyber threats. Implementing robust cybersecurity solutions is essential for ensuring the safety and security of medical devices, meeting FDA and ISO compliance, and upholding safety, security, and reliability standards for both users and patients.
CYBERSECURITY SOLUTIONS
We offer a full suite of cybersecurity solutions, from assessments to strategy development and compliance readiness. Our solutions include:
Governance, Risk and Compliance Assessment
Evaluating governance, organizational structures, and quality practices to ensure alignment with a compliant cybersecurity program, providing a roadmap to address gaps and risk.
Maturity Assessment & Evolution
We assess your current quality systems and development processes for cybersecurity compliance, identifying gaps and implementing best practice approaches to improve your system’s maturity.
Architecture Assessment & Strategy
Assessing your quality systems and development processes for cybersecurity compliance, identifying gaps, and implementing best practices to enhance system maturity.
Product Evaluation & Modernization
Products are evaluated for cybersecurity risks, with cost-effective remediation strategies tailored to risk levels and regulatory standards.
Cybersecurity Submission Readiness
MedAcuity audits your DHF and submission artifacts for cybersecurity compliance, helping minimize submission risks and ensure a smoother approval process.
Answering Critical Cybersecurity Questions
Do I have an effective cybersecurity program?
We evaluate your governance, organizational structure, and QMS elements to ensure your medical device meets safety, security, and compliance standards.
How do I navigate complex regulatory requirements?
MedAcuity ensures your product development aligns with FDA and ISO standards for successful regulatory submissions.
Have we made the right design choices?
We guide you on integrating cybersecurity into key design elements like requirements, risk controls, and architecture for secure, compliant products.
What is our risk exposure for existing and updated products?
We evaluate your products against the latest cybersecurity standards to minimize exposure to cyber threats and regulatory risks.
Do I lack internal cybersecurity expertise?
MedAcuity provides expert cybersecurity solutions to meet all regulatory and security requirements without needing in-house expertise.
How can I reduce the risk of submission rejections?
We address potential cybersecurity compliance issues early to optimize your submissions.
Are third-party components secure?
We assess third-party software, chips, and cloud services to prevent security vulnerabilities in your products.
trusted partner
MedAcuity has extensive expertise in medical device cybersecurity, helping companies build secure, FDA and ISO-compliant products. Unlike regulatory-focused firms, we combine systems engineering and device development to create secure, effective solutions. We leverage insights from diverse projects to deliver the latest cybersecurity practices to every client.
Achieve Compliance & Mitigate Risk
MedAcuity simplifies cybersecurity compliance for medical devices, ensuring your products are secure, compliant, and market-ready, with a focus on:
- Submission Optimization
- Risk Mitigation
- FDA, ISO, IEC Compliance
CONTACT MEDACUITY FOR YOUR CYBERSECURITY NEEDS
Get in touch with our cybersecurity experts today to ensure your medical device meets the latest security standards and is ready for a smooth regulatory submission process. Let MedAcuity guide you through the complexities of cybersecurity and compliance in the medical device landscape.
Expertise
Get to know our capabilities better. Check out some of our Insights articles and recent projects.
INSIGHTS ARTICLES
Healthcare Cybersecurity Challenges: Securing Medical Devices & Data Protection
Effective Strategies for OEMs
Project Snapshots
Clear Requirements: A Blueprint for Success
How clear & well-defined requirements shape software development success
NEWS ARTICLES
Improving Medical Device Security with Adversarial Thinking
The best defense for a cybersecurity attack in medtech is a strong offense