BSI TR-03161 for DiGA – Implementation & Consulting

We help you to implement BSI TR-03161 within your digital health application (DiGA) quickly and securely. The common goal: to pass the BSI audit smoothly and obtain your BSI certification.

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Our Expertise:
Implementation of BSI TR-03161 for DiGA

Thanks to our experience in the development of DiGA and the implementation of data security requirements, we are your ideal partner for the implementation of BSI TR-03161.

Our services include:

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Gap Analysis

Identification of loopholes in your existing software product and processes.

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Technical Implementation

Integration of BSI-compliant security requirements into your digital healthcare application and processes.

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Preparations for Audits

We ensure that you are optimally prepared for the BSI audit. We also support you in preparing the necessary documentation.

Benefits of our Cooperation

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Time Saving

Fast and precise implementation of BSI specifications, without detours.

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Know-how

Our team is familiar with the challenges of TR-03161 and has already successfully supported numerous projects.

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Individual Consulting

We customize our solutions to your specific requirements.

How we work together

1

Initial Analysis

We evaluate your existing product and identify gaps that need to be closed before BSI certification.

2

Customized Implementation

Our software team implements all the necessary measures within your product or advises you on internal implementation.

3

BSI Audit Support

We prepare you comprehensively for the audit and support you in communicating with the inspection bodies.

What really sets us apart

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ISO 13485 certified

Our quality management system is certified according to ISO 13485. In this way, we ensure the necessary quality of medical software.

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Data Protection and Information Security

QuickBird Medical is ISO 27001 certified for information security. We are experts in the areas of cybersecurity and health data protection.

Do you need BSI TR-03161 for your DiGA?

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Contact us for a non-binding initial consultation. We will carry out an initial analysis of your existing product and accompany you on the way to successful BSI certification.