SOFTWARE COMPLIANCE
We have expertise in providing efficient and cost-effective solutions for Software as a Medical Device (SaMD) or Software as a part of Medical Device/IVDs and international standards.
We can work with you to develop protocols and plans throughout the Software Development LifeCycle (SDLC) as per FDA and international standards.
SaMD
Software as a device that does not require any hardware or chemistry for the intended use
AI/ML Software
Artificial Intelligence (AI) and Machine Learning (ML) based IVDs/Devices
Software for Operations
Software used for managing operations including eQMS and Clinical Trials
Software in a Device
Software as an integral part of the device/IVD for the intended use
Software Validation
Including software verification, software documentation, and execution of IQ/OQ/PQ
30 years
Our team members have been serving the life science industry for more than 30 years.
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