MDR CLASS IIa/IIb & SaMD EXPERTS
Security for Critical
Medical Devices.
Specialized penetration testing for MDR Class IIa/IIb, SaMD, and AI. We bridge the gap between offensive security and IEC 81001-5-1 compliance to get your device certified.
Our Services
We provide a comprehensive suite of cybersecurity services to protect your business from ever-evolving digital threats.
Penetration Testing
Professional penetration testing that thinks like attackers do – uncovering vulnerabilities before malicious actors can exploit them. We provide Risk-Prioritized Vulnerability Findings mapped to CVSS/CWE standards, enabling your engineering team to fix critical safety risks immediately.
Security Consulting
Strategic security consulting from seasoned experts. We provide guidance on tailored security architectures that scale with your business growth and proactively meet regulatory requirements.
Secure Code Review
Thorough code analysis by experienced developers – we don't just find security flaws, we provide actionable fixes. Reduce risk and accelerate secure releases.
Application Security
Our security expertise spans across various application types and technologies, ensuring comprehensive protection for your digital assets.
Mobile App Security
Comprehensive security audits and penetration testing for iOS and Android applications to identify and remediate vulnerabilities before attackers can exploit them.
Web Application Security
In-depth vulnerability assessments and security testing for web applications, protecting against OWASP Top 10 vulnerabilities and beyond.
API Security
Expert analysis and testing of API endpoints to prevent unauthorized data access, ensuring secure resource access control and proper authentication.
AI Security
Specialized security assessments for AI/ML models, focusing on model manipulation, data extraction risks, and prompt injection vulnerabilities.
Focus Areas
We specialize in providing tailored security solutions for specific industries and company types, with a deep understanding of their unique challenges.
Medical Device Manufacturers
Audit-ready security assessments for MDR Class IIa/IIb manufacturers. We provide technical evidence for Notified Body certification, validating the security outcomes required by IEC 62304 and IEC 81001-5-1.
Startups
Agile security solutions designed for fast-moving companies, balancing robust protection with the need for rapid development and growth. We help startups meet compliance requirements and build customer trust from day one.
Small Businesses
Right-sized security solutions for small teams and businesses, making professional-grade cybersecurity accessible without enterprise-level budgets or resources. We support regulatory compliance and practical risk management for growing companies.
Our Specializations
We focus on the most critical and complex areas of cybersecurity, providing deep expertise where it matters most for your regulatory compliance and business success.
MDR Class IIa/IIb Security
Security testing and validation for SaMD according to IEC 81001-5-1.
DiGA Security & BSI Compliance
Your expert partner for DiGA compliance – we provide specialized consulting to implement BSI TR-03161 requirements and prepare your application for successful BfArM approval.
AI/LLM Security
Cutting-edge security assessments for AI and Large Language Model applications, addressing emerging threats in machine learning systems.
Mobile Application Security
Deep mobile security expertise covering iOS and Android applications with focus on advanced protection mechanisms and compliance requirements.
Web Application Security
Comprehensive web application security testing covering modern frameworks, single-page applications, and complex business logic.
Backend & API Security
In-depth backend system and API security assessments, including cloud infrastructure and microservices architectures.
Need Expert Security Assessment?
Whether you're preparing for regulatory approval or strengthening your security posture, we have the specialized expertise to guide you through the most complex requirements.
Schedule Expert Consultation NowThe Machine Spirits Advantage
Machine Spirits brings together academic rigor and industry leadership to deliver specialized cybersecurity expertise for your most critical assets.
Professional Security Expertise
Our qualified team combines academic precision with 25+ years of real-world experience. The result: Deep security analysis that not only uncovers problems but provides cost-effective solutions – accelerating your time to market and increasing customer confidence.
Tailored Security Solutions
No one-size-fits-all solutions – we design security strategies perfectly aligned with your technology and business goals. Minimize risks without unnecessary costs while accelerating your compliance journey.
Results That Drive Business Value
Instead of complex reports, you get clear, prioritized action plans with concrete implementation steps. Your teams can start immediately, reducing risks while keeping time and budget in focus.
Understanding the Notified Body Mindset
We bridge the gap between offensive security and regulatory compliance. Our expertise in MDCG 2019-16 and IEC 81001-5-1 means we deliver the independent security validation Notified Bodies require, not just vulnerability lists. We speak both languages: technical depth and audit readiness.
Protect Your Digital Business – Starting Today
Begin with a professional security assessment and get actionable steps to protect your valuable data.
Our Team
Meet our qualified penetration testing experts who combine academic research excellence with decades of practical cybersecurity experience, specializing in medical device security and regulatory compliance.
Dr. rer. nat. Simon Weber
Lead Penetration Tester & Medical Device Security Researcher
PhD security researcher who found critical vulnerabilities in hospital systems. Leading member of MedSec research group. Simon turns academic rigor into practical solutions that protect real patients.
Dipl.-Inf. Volker Schönefeld
Senior Penetration Tester & Application Security Expert
20+ years as CTO. 50+ million app downloads. Teams up to 35 experts. IoT fleets with thousands of devices. Volker brings deep security expertise and makes complex compliance simple.
Our Achievements & Expertise
Medical Device Compliance
Expert penetration testing for SaMD and DiGA applications following industry standards
Academic Research
PhD-level research in hospital security and critical infrastructure protection
Practical Experience
Extensive hands-on security testing and continuous professional development
25+ Years Combined
Extensive experience in cybersecurity, development, and regulatory compliance
What Our Clients Say
Trusted by leading companies for their security needs
“Machine Spirits helped uncover vulnerabilities in our platform early with a structured and in-depth pentest before we went through MDR certification. The clear reports and pragmatic communication helped us quickly close security gaps and efficiently update our documentation.”
“As a security partner for our DiGA, Machine Spirits impressed us with their in-depth pentests. Their competent TR-03161 consulting and clear recommendations were crucial in meeting the demanding BSI requirements quickly and securely.”
“Very pleasant collaboration with Volker and Simon from Machinespirits. Both are extremely professional and very flexible. We would be happy to continue working with Machinespirits in the future.”
Contact Us
Ready to secure your digital assets? Our team of cybersecurity experts is here to help.
Phone
+49 221 65031192Response Time
We typically respond to all inquiries within 24 hours during business days.
Average response time: 6-12 hours