Best practices and industry standards are part of our DNA. Our research is conducted according to the guidelines found in IEC 62366-1, TR 62366-2, FDA guidance on applying HF/UE to medical device development, AAMI HE75, and other standards wherever appropriate.
We comply to the question catalogue of information security of the German Association of the Automotive Industry (VDA ISA) and have implemented an ISMS to protect the confidentiality, availability and integrity of information. The assessment was conducted by the TISAX® audit provider DEKRA. The result is exclusively retrievable over the ENX portal. (Scope ID: SX7HT0 – Assessment level 3). TISAX® and TISAX® results are not intended for general public. TISAX® is governed by ENX Association.