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Medical Devices



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Join us at embedded world 2019

We will be attending embedded world, the leading international exhibition for embedded systems, in Nuremberg from 26 to 28 February 2019. The Lorit Consultancy team will be on stand 4A-309 to speak with organisations who are looking for Functional Safety and...

Part 2: ISO 26262 – Elementary Hardware

In the first part of our blog we looked at the process of evaluating hardware elements in ISO 26262. In part 2 we will look at the three classes of hardware element and how the process of their evaluation relates to ISO 26262-5:2018.     Thus...

ISO 26262 – Elementary Hardware

ISO 26262-8:2018, Section 13 - Evaluation of hardware elements - aims to address the safety compliance of commercial off the shelf (COTS) hardware devices (device we are using to avoid confusion with other terminology). One area here that could be enhanced is the link...


“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