IT Security

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Gain clarity: Understand the IT security requirements for medical devices and implement them in a standards-compliant manner

Clarity about What to Do and How to Proceed

We create your customized roadmap so that you know who has to do what and when. It allows you to plan budgets and marketing reliably and with the certainty of not forgetting anything.

Certainty for Audits and Approvals

There is no need to sweat when file reviews are pending – with our experts at your side, you are well-prepared for any audit or review. ​​​​​​
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Fast and Plannable Implemen­tation

With us, creating your cybersecurity file becomes a sprint. That way, you can impress with quick results, and your company will have secure devices that quickly succeed in the market.  

Expert and Insider Knowledge

Our experienced experts know exactly what autho­rities and notified bodies expect. They are even involved in writing new standards and co-authored the guideline for notified bodies.

Single Source

Our more than 100 experts are also available to help you with other topics as needed, such as risk management or the usability of your medical devices.

Valuable Templates

You benefit from templates that have proven themselves countless times in audits and re­views. That puts you on the safe side and saves time and money. 

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We will guide you safely through all the regu­latory hurdles in the field of IT security, e.g., in accordance with IEC 81001-5-1 or FDA

With the increasing prevalence of connected devices and the use of IT systems in healthcare, cyber-attacks and other IT security incidents are becoming more likely. It's up to the manu­fac­turers to take appropriate preventive measures – a demanding and often overwhelming task.

The topic of IT security is causing headaches for many: There are too many unfamiliar technical terms and too many standards and require­ments that are difficult to understand. In addi­tion, there is uncertainty about what authorities and notified bodies actually want to see, which methods and tools are most suitable, and which documents ultimately belong in the cyber­secu­rity file. Where should you even start? 

Our experts ensure that IT security is guaranteed throughout the entire product life cycle

Whether you are looking for an overview, need help with specific tasks quickly, or want to out­source the creation of your cybersecurity file entirely due to a lack of time and resources, we have the right solution.

Knowledge Transfer, Instructions, and Templates for the Cybersecurity File

In our seminars or workshops, our experts will clarify the basics with you:

  • What do the individual terms mean, and in what context are they used?
  • Which regulatory requirements for IT security must be considered (e.g., IEC 62344, IEC 81001-5-1, NIST, FDA, MDCG)?
  • How do the requirements relate to the terminology? Which methods to use when?
  • In which order and with which priorities should one proceed?
  • Which documents must be created and belong in the cybersecurity file?

This overview forms the basis for the next step, jointly creating a concrete project plan. We provide you with our proven templates for successful implementation on your own. Our team is happy to review and answer any open questions after each step. 

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Hands-on Workshops on Individual Topics

Through targeted and customized workshops, we help you with the:

  • formulation of IT security requirements for your device,
  • creation and evaluation of security criteria,
  • performance of risk analyses (threat modeling) and linking with the product risk analysis according to ISO 14971,
  • planning and execution of IT security tests (e.g., vulnerability scanning or penetration tests),
  • seamless integration and linking of IT security processes into your quality management system, and
  • selection of suitable external service pro­viders. 

Development and Integration of an ISMS in Accordance with ISO 27001

Do you still need an information security management system (ISMS) according to ISO 27001? Our team will help you set it up and integrate it with other management systems in your organization. 

Learn more​​​​​​​​​​​​​​

Penetration Testing for Devices and Systems

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Our IT security experts use targeted pen tests to simulate cyber-attacks on your software-based devices, infrastructures, and/or networks, unco­vering security vulnerabilities that hackers could potentially use to gain access. 

Learn more​​​​​​​​​​​​​​

Creating/Improving/Checking Documents

Our team can create all the necessary device-specific documents for you, carry out gap analyses, and correct errors. That way, you will receive compliant approval documents to submit directly. 

Processing of Deviation Reports

Even if the authority or notified body has already found deviations or you have concerns, help is available. You can also rely on our support in processing deviation reports.

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Contact us now to find the best form of support for your IT security needs.

Contact us, we're happy to help!
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