Cybersecurity for Medical Devices

GAP Analyses • Threat Modelling • Risk Assessments • Ensuring NIS-2 Compliance

EXCO - Your Partner for Cybersecurity in MedTech & Pharma

As medical devices become increasingly connected, the risk of cyberattacks, manipulation, and data breaches continues to grow. Effective IT security is essential to ensure patient safety, product security, and long-term compliance.

Our EXCO specialists support you in all aspects of IT security, from analysis through to implementation. We assess the legal and regulatory requirements applicable to your organization and ensure compliant, audit-ready implementation.

EXCO Services

Cybersecurity Beratung für Medizintechnik und Pharma - NIS 2

Cybersecurity Consulting & Analysis

We advise you on all aspects of cybersecurity in the regulated pharmaceutical and medical technology sectors, from your IT infrastructure and processes to specific security requirements for your medical devices.

Our methods:

  • Interviews with stakeholders
  • Checklists and gap analyses
  • Specific and pragmatic recommendations for action
  • Evaluation of existing documentation
Analysis and evaluation of cyber risks to improve the security of IT systems and applications.

Risk Analysis & Assessment (STRIDE and NIST CVSS)

For software-based medical device development, we conduct product-specific security risk assessments, including:

  • Mapping assets and interfaces to risks
  • Threat modelling using STRIDE
  • Risk matrix development
  • Severity assessment using NIST CVSS
  • Derivation of specific security measures
Support for risk analyses and safety assessments during the development and regulatory approval of medical devices.  Geben Sie Ihr Feedback zu BizChat ab.

Security Measures & Implementation

We help you prioritize and implement identified recommendations as well as your own security initiatives. This enables you to address critical risks early, maintain compliance, and safeguard both patient safety and process stability.

Our Services:

  • Templates and process development
  • Comprehensive process documentation
  • Seamless integration into QMS and existing processes
  • Ensuring NIS2 compliance

Contact us

Your Contact

Dr.-Ing. Alexander Klaus

IT Quality Services

+49 6233 73778-136

Get in touch with our EXperts

Your data will only be used to respond to your inquiry and will not be shared with third parties. For more information on how we handle your personal data, please see our Privacy Policy.

Please calculate 9 plus 3.
Laboratory environment supporting conformity assessment, regulatory approval, and market access under MDR and IVDR.

EXCO Sevices

EXplore our EXCO Services

As a full-service provider, we support SMEs and large corporations with high-quality technical solutions in software engineering, systems development, automation, and quality assurance for highly regulated markets. Our customers include companies in the medical technology, pharmaceutical technology, biotechnology, chemical, and food technology sectors, as well as other regulated industries.

Discover EXCO

FAQ

FAQs - About EXCO

As a global technical service provider, EXCO supports companies in regulated industries throughout the entire product lifecycle, from development and quality assurance to regulatory affairs and product approval. Explore our complete range of services: EXCO Services

Since 1994, EXCO has been synonymous with technical expertise and practical solutions for regulated industries. Today, more than 200 employees across 8 locations support customers worldwide with development, quality assurance, and regulatory approval projects.

We focus on the medical technology, pharmaceutical technology, biotechnology, chemical, and food technology sectors, as well as other regulated industries.

As an ISO-certified company (ISO 13485 and ISO 9001), EXCO delivers high-quality technical solutions in software engineering, systems development, automation, engineering, and quality assurance. We support our customers throughout the entire product lifecycle, from initial concept and development to regulatory approval, post-market surveillance, and ongoing product improvement. Explore our full range of services: EXCO Services.

EXCO is headquartered in Frankenthal (Pfalz), Germany, with additional locations across Germany and a subsidiary in Switzerland, EXCO Consulting GmbH. This regional presence enables us to provide flexible, responsive support close to our customers.