Software

Regulated Software Development

Software as a Medical Device (SaMD),
Software in a Medical Device, or
Software used in manufacturing

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.

We can work with you to develop protocols and plans throughout the Software Development LifeCycle (SDLC) as per FDA and international standards.

Software as a device that does not require any hardware or chemistry for the intended use

Artificial Intelligence (AI) and Machine Learning (ML) based IVDs/Devices

Software used for managing operations including eQMS and Clinical Trials

Software as an integral part of the device/IVD for the intended use

Including software verification, software documentation, and execution of IQ/OQ/PQ

30 yrs

Our team members have been serving the life science industry for more than 30 years.

100%

return and retention rate

We are proud that we are able to build and trust with our clients and retain of clients for multiple years.