Materialise values quality management principles according to ISO9001:2015, with a strong focus on customer satisfaction and continuous improvement. On a regular basis, we perform customer surveys or customer journey workshops to receive customer input. This triggers and enables us to constantly improve the entire organization. All the processes at the Materialise Software division are ISO9001 certified. This certificate can be found on our website: https://www.materialise.com/en/about-materialise/quality   

Materialise touches individual lives with our medical devices, and every resulting story is unique. Each step in designing and manufacturing personalized medical devices and medical device software follows the regulatory-focused quality management system for medical devices compliant with ISO 13485:2016 to ensure safe and effective products.
However, this standard applies strictly to our Medical division, while Magics itself is developed within the Software division.  Magics itself is not a medical device and is thus not developed within a ISO13485 certified process, but within a ISO9001 certified process.

TISAX stands for "Trusted Information Security Assessment Exchange." It is a standard and assessment framework specifically designed for the automotive industry to ensure the secure exchange of sensitive information among companies in the supply chain.
Materialise Software has obtained a Tisax certification, for its own (internal) IT-systems and own data security,and for secured data transfer with a TISAX-bound customer.  Materialise has a Level L2 certification, which can be verified by companies that are member of the ‘Tisax / German Association of the Automotive Industry (VDA)’.
Magics itself is a desktop software (not hosted in the cloud) and therefor the TISAX certification does not apply to Magics as a product.

Magics does not have any medical certification nor clearance, unlike e.g. our medical products that do have certain medical clearances (such as a 510k clearance).  
The reason for this is that the intended use of Magics is not specifically aiming at medical processes, hence it is not considered a medical device as such. However, this does not mean that Magics cannot be used in a certified or cleared medical process.  

As from Magics 26 onwards, the international VPAT document is available upon request.  This combines the following standards:

• VPAT 2.4 Rev 508: Revised Section 508 standards – the U.S. Federal accessibility standard
• VPAT 2.4 Rev EU: EN 301 549 – the European Union’s “Accessibility requirements suitable for public procurement of ICT products and services in Europe”
• VPAT 2.4 Rev WCAG: ISO/IEC 40500 (equivalent to WCAG 2.0) 
   

Magics is a C++-based desktop product, and as such has a limited network connection.  But, concerning network connections, Magics communicates as a client with the following internet applications:

• Send usage data to Application insight (opt-out)
• Magics communication tool HTTP GET

In addition, there are some connections to localhost windows services where WCF and tcpip is used.

• Licensing service
• BPSystem
• Materialise Plugin System

Optionally (if configured) Magics can also communicate with other Materialise products via the following ways:

• WCF Connection to Streamics 
• gRPC calls to CO-AM

Magics is a C++-based desktop product, developed in-house by Materialise, but it integrates various 3rd party components, that are mentioned in the “3rd party software overview” that comes with the software (accessible via the ‘about info’ in Magics).  A full overview of the Bill of Materialise (BOM) can be obtained upon request for each version of Magics and Magics components (such as e-Stage, Simulation module, MatConvert, ...).

The Magics product currently does not have a ECCN, but this is an ongoing process.

The CO-AM environment is ITAR compliant and controls who has access to ITAR parts or not.  Magics itself is ITAR aware (if the parts are coming from CO-AM), and will inform the user when ITAR parts are used in non-ITAR builds.

Magics RP is tested and compatible to run in a FIPS-enabled environment.