Safety Projects in Medical Technology: CANoe MedTech From Vector Receives TÜV Certificate
Reduced Effort for Tool Qualification When Developing Safety-Related Medtech Systems
Stuttgart, Germany, 2026-05-12 – TÜV SÜD has certified Vector's CANoe platform. Medical technology developers now have an independently tested tool at their disposal for the first time that meets the requirements of IEC 62304, the central standard for developing medical software.

TÜV Certification Scope
TÜV SÜD has certified four products from the CANoe family as T2 offline support tools for safety-related development projects: CANoe, CANoe MedTech, CANoe Server Edition, and CANoe MedTech Server Edition. All are qualified for all software safety classes according to IEC 62304.
The certification covers the central functional areas:
  • Communication analysis – analyzing communication flows in embedded systems
  • Simulation – Virtual and real testing of system behavior
  • Automated testing – from individual software components to the entire system
  • Diagnosis & stimulation – Targeted fault injection and reaction analysis
User Benefit: Less Qualification Effort
Projects in accordance with IEC 62304 require proof that the tools used meet the safety requirements – a time-consuming process. The TÜV certificate relieves users of a large part of this work: the independent assessment is already available, saving time on audit preparation and increasing planning reliability – especially with the long product life cycles that are common in medical technology.

Ensure Long-Term Reliability With Regular Recertification
In addition to IEC 62304 (MedTech), the CANoe platform tools have also been certified for IEC 61508, ISO 26262 (Automotive) and EN 50716 (Railway). Vector plans to renew the certifications regularly. This means that future CANoe versions will also meet the requirements of the relevant safety standards, so customers can rely on a tested, future-proof tool in the long term.

More information at: www.vector.com/canoe
About Vector

Vector is a leading solution provider and a trusted partner in the development of software-defined systems. For over 35 years, Vector has empowered OEMs and suppliers worldwide to realize complex electronic products that meet the highest standards of functionality, safety, and efficiency—primarily in the automotive industry, and increasingly in medical technology, IoT, rail, and aerospace. At the core of Vector’s portfolio is a comprehensive software ecosystem that seamlessly integrates tools, embedded software, cloud services, and engineering expertise into a high-performance development environment. Driven by technological excellence and close collaboration with customers and partners, Vector delivers tailored solutions that simplify complexity, accelerate development, and enable forward-looking innovation.
As an independent company, Vector employs more than 4,500 people across 32 locations worldwide and generated revenues of more than 1 billion euro in 2024. Headquartered in Stuttgart, Germany, Vector maintains a global presence with subsidiaries in Austria, Brazil, China, France, the United Kingdom, India, Italy, Japan, South Korea, Romania, Sweden, Spain, and the United States.
 
 
 
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» Press Release
Date: 12.05.2026 09:00
Number: CANoe_Safety-Certificate EN - MedTech
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Figure 1: Vector's CANoe development and testing tool is now safety-certified. This reduces the qualification effort for safety-related systems in the automotive, MedTech and railway industries Image rights: Vector Informatik GmbH

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Figure 2: The CANoe development and testing tool from Vector is certified to the general IEC 61508 standard, the IEC 62304 for MedTech as well as the ISO 26262 for automotive, and the EN 50716 for railway. Image rights: Vector Informatik GmbH
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Ingersheimer Str. 24
70499 Stuttgart/Germany

Cordula Gielen
Tel. +49 711 80670-2910
E-Mail: Cordula.Gielen@vector.com

Vector press contacts worldwide you will find at: www.vector.com/press

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