Cybersecurity
Your partner for secure, compliant MedTech Products in the Digital Era
StingOrg helps you establish cybersecurity as an integral part of your product and process quality. Our expertise combines regulatory requirements with practical security architecture – from development to post-market support. This strengthens not only the resilience of your systems but also the trust of your customers and authorities.
Think security strategically, ensure regulatory compliance, implement practically
Cybersecurity is not just an IT topic. In MedTech, it is a structural factor for quality, product safety, and compliance. We support you in developing and implementing robust security concepts throughout the entire product lifecycle – standards-compliant, audit-proof, and realistically applicable in day-to-day operations.
Our services start with risk analysis and threat modeling during development and extend to vulnerability monitoring after market launch. We help you efficiently integrate regulatory requirements into your processes and technical documentation.
Our projects range from gap analyses to building a Secure Product Development Framework (SPDF) and embedding security processes into your QMS. A lived security awareness beyond market introduction – within post-market and vigilance processes – is a key component of corporate responsibility for information and ultimately patient safety.
Results of our work:
- Secure, auditable software development processes
- Verification and validation with traceability to requirements
- Security (Risk) Management Plan and Report
- Embedded security processes in the QMS
- Clear responsibilities & maturity models
- Reduced security risks and compliant products
Success Factors:
- Regulatory-compliant development processes
- Reduction of cybersecurity-related incidents
- Sustainable process security in operations
- Targeted competence building within the team
Our work does not end with the security concept. We support you in embedding it within your organization – through structured training, maturity checks, and continuous improvement. Because cybersecurity is not a project – it’s a process.
Our Services
Cybersecurity from the Start:
Integration of security requirements into development, design, and architecture
Security in Operations:
Patch/update management, software bill of materials (SBOM), monitoring and assessment of vulnerabilities and threats, transparency requirements, supplier security
Security meets QMS:
Embedding regulatory requirements into your quality management system
Your Benefits
Compliance & Trust:
Secure products that meet regulatory standards and build trust
Risk and Cost Minimization:
Early assurance of product security – before launch and in the field
Sustainable Protection:
Structural integration of security into your organization and processes
Our Promise
Deep knowlegde:
Technology, processes, and regulatory requirements from a single source, backed by deep domain knowledge in medical technology
Practical Orientation:
Implementable solutions tailored to the product’s risk profile and intended use
Long-Term Protection:
Security concepts that last across product cycles
Dirk Müller, Senior Consultant
Our Cybersecurity Experts
Our teams bring years of experience in securing digital medical products. We guide you from strategy to implementation to achieve compliance to IEC 81001-5-1, MDR and FDA requirements. We ensure you identify product security risks early, prioritize them correctly, and resolve them sustainably in a pragmatic way.
Our Core Areas: Your Advantages
Product Security Throughout the Entire Lifecycle
Compliance with EU and FDA Requirements
Gap Analysis and Audit Expertise
Do you have questions?
For specific questions and more detailed information we offer you specific Webinars and Q&A sessions. You can receive precise answers on your requests and additionally comprehensive information.
Do you want to move
your business forward?
Let’s take the first steps together!