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.
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.
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.
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.
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.
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.
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?
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.
In our seminars or workshops, our experts will clarify the basics with you:
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.
Through targeted and customized workshops, we help you with the:
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.
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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.
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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.
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.
Contact us now to find the best form of support for your IT security needs.
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Exclusive in-house bundle combines regulatory compliance (IEC 81001-5-1) with secure coding. Five-day practical training reduces market access risks and avoids costly audit deviations through in-depth security expertise.
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