Lorit Consultancy offers consultancy, support and training in functional safety related projects. From the concept phase through to start of production, we can assist you with the complex exercise of international standards compliance (IATF 16949, ISO 26262, IEC 60601-1, IEC 62304, and many more). The key sectors supported are medical, automotive and reliability.
The development of medical devices is driven by risk identification and mitigation. Let´s take a defibrillator as an example. To ensure that this device fulfils the safety requirements defined in standards such as IEC 60601 and its particular standard 60601-2-4 is a...
We are entering the fifth year after the IATF 16949:2016 standard has been published. The due date for the transition audit from old standard version ISO/TS 16949:2009 to the new version IATF 16949:2016 was mid of September 2018. So by now the affected organizations...
We are happy to announce that this February will be our 3rd time at the embedded world in Nuremburg. Embedded world is the leading international trade fair for embedded system technologies and takes place from 25 to 27 February 2020. It promises to be one of...
“Lorit Consultancy gave us great support when guiding us through the process of hardware metric generation as defined in ISO 26262. Providing both the FMEDAs and training on the use of them.”
Geoff Owen Protean
“Lorit Consultancy provided a professional and efficient service in defining regulatory requirements for both new developments and legacy products.”
Alastair Mutch – VP Research and Development, Diagnostics Cardiology Spacelabs Healthcare