Lorit Consultancy offers consultancy, support, training and online-courses in functional safety related projects in the medical, automotive and reliability sectors. Through years of successful work with international and geographically distant customers we have already gained a lot of experience in working remotely. Therefore, we can assist you – even under quarantine conditions – with the complex exercise of international standards compliance (IATF 16949, ISO 26262, IEC 60601-1, IEC 62304, ISO 14971 and many more) from the concept phase through to start of production.
Soft errors are well known in the informatics as special form of errors, which could cause an unexpected and unintentional state of a logic circuit or data memory. Other than errors caused by defects in the hardware which permanently change the system, only temporary...
One of the key topics over the last few years in the medical device sector is the introduction of Software as a Medical Device SaMD. The activities initially driven by the International Medical Device Regulators Forum (IMDRF) then finding its way into standards such...
In the first part of this blog (Software Safety Analysis Part 1) we looked at requirements management and traceability as key activities in the reliable implementation of software projects. In this part of the blog we look at the importance of a qualitative overview...
“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