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Proof of quality for IT security

Make reliable security visible – with the NewTec IT security certificate.


Our IT security certificate helps you to provide evidence of your product's compliance with legal requirements – such as CRA, RED2, NIS2 – and thus make your product future-proof and market-compliant today.

Customers and partners – as well as legislators – are placing increasingly high demands on the independence, transparency, and traceability of the security measures of products and services. In response, NewTec GmbH conducts structured, context-specific security assessments and issues security assessment certificates confirming that no critical vulnerabilities were identified within the defined scope of the investigation and based on the agreed methods.

For providers, the certificate is a strong argument vis-à-vis regulatory authorities (e.g., FDA, EU notified bodies) and serves as proof of quality. It transparently documents that the legal IT security requirements are taken seriously. For buyers and customers, it creates trust: a product with an attestation meets defined security requirements and signals that the manufacturer understands IT security as a key quality feature.


What is tested?

As part of the security assessment, we, as an independent organization, review both the design and practical implementation of the product. The IT security certificate only issued if no critical vulnerabilities are found.

Our neutrality and expertise guarantee an objective evaluation—as reliable proof of quality, even in the context of regulatory requirements such as CRA & Co.


How is testing carried out?

The security assessment follows a structured, multi-phase approach based on established standards such as IEC 81001-5-1, IEC 62443-4-1, and ISO/IEC 21434. Link to Security Assessment Prozess


What does the attestation include?

  •     A detailed certificate report,
  •     the official attestation certificate with specified security features,
  •     an entry in our public certificate list on this website,
  •     upon request, a publicly accessible white paper that presents the audited security measures in a generally understandable manner.


Who performs the assessments?

NewTec performs assessments with cross-functional teams of experts. Depending on the product and context of use, we combine cybersecurity analysts, penetration testers, domain experts, and requirements specialists to form an optimally coordinated assessment team. Thanks to our experience in highly regulated industries and our strength in audit quality and documentation, we deliver comprehensible and reliable security assessments – even in regulatory environments.

 

IT security certicate: Trust through transparency

Below you will find an overview of the certificates and attestations that have already been issued. Each document certifies the tested safety quality.

 


Security Assessment Certificate, Roche Diabetes Care GmbH, Accu-Chek SmartGuide app

Roche Diabetes Care GmbH, Sandhofer Straße 116, 68305 Mannheim, Germany

Produktversion: Accu-Chek® SmartGuide app – v1.2.0
Zertifikatsnummer: 26-0001
Abschluss der Security Assessments: Dec 2025
Ausgestellt: Jan 2026
Gültig bis: Feb 2028

Download: Testat_Roche_Accu-Chek SmartGuide app



Security Assessment Certificate, Roche Diabetes Care GmbH, Accu-Chek SmartGuide device

Roche Diabetes Care GmbH, Sandhofer Straße 116, 68305 Mannheim, Germany

Product Version: Accu-Chek® SmartGuide device - FW 8.0.0
Certificate Number: 26-0002
Finalization of Security Assessment: Dec 2026
Issued: Jan 2026
Valid Until:Feb 2028

Download: Testat_Roche_Accu-Chek SmartGuide device


 

Interested in your own attestation?

If you would like to have your product independently tested and certified with an IT security attestation and the necessary proof of conformity (e.g., for CRA market entry), we will be happy to assist you. We provide personalized advice and guide you transparently through the entire testing process—from conformity assessment to documentation of security measures.

Your contact person
Kontakt - Matthias Lai
Matthias Lai
Senior Security Consultant

NewTec GmbH
Buchenweg 3
89284 Pfaffenhofen a. d. Roth
Phone +49 7302 9611-0
Kontakt


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