Product Software Validation
Software has become the heart of any technological application over the last 30 years.
In the medical field, the correlation between software and the safety of medical devices has become a synonym.
The new EU MDR745/2017 deals with the regulation of the Software both stand alone and integrated into the Medical Device, in a much more detailed way than in the past, raising, with relevant classification rules, the risk class of many stand-alone software.
Our team includes experts who have gained a multi-decade experience in the validation of software for medical use in the international field, with positive assessments on the validations performed by Interactional Authorities such as FDA.
Maytal can support companies, from the early stages of software design, to define the level of software risk, to provide the basis for the designers in defining the software life cycle in accordance with IEC62304, in the definition of the requirements, up to the planning of the tests and the closure of the validation, proposing practical solutions that allow the R & D sector to produce the necessary documentary evidence to support the validation of the software.
In the medical field, the correlation between software and the safety of medical devices has become a synonym.
The new EU MDR745/2017 deals with the regulation of the Software both stand alone and integrated into the Medical Device, in a much more detailed way than in the past, raising, with relevant classification rules, the risk class of many stand-alone software.
Our team includes experts who have gained a multi-decade experience in the validation of software for medical use in the international field, with positive assessments on the validations performed by Interactional Authorities such as FDA.
Maytal can support companies, from the early stages of software design, to define the level of software risk, to provide the basis for the designers in defining the software life cycle in accordance with IEC62304, in the definition of the requirements, up to the planning of the tests and the closure of the validation, proposing practical solutions that allow the R & D sector to produce the necessary documentary evidence to support the validation of the software.
