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Medical Devices

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Medical Devices

Fine tuned advice and execution based on proven methodologies!

Pre and Post Market compliances

We bring your Medical Device, Implants, Software (SaMD), DDx, DTx, combination, wearable, and IVD products to the market and keep it there, by advising on “go to market strategy” & drafting documents needed for 510(k) clearances, DeNovo, PMA approval, CE Marking, ISO 13485, MDR compliance & more. Elexes offers an end-to-end solution for companies in the field of:


What we offer


Regulatory approvals are mandatory to legally sell. Elexes has helped companies expand their businesses by partnering with them to execute end to end approval and clearance processes. Some of the most common services that companies have benefited from while working with Elexes are as follows:


We provide customized quality system solutions that are tailored to your organization, because when it comes to quality systems “one size does not fit all”. Amongst the various premarket and post-market quality systems support that Elexes has provided, the following have been the most popular ones:


Companies often get busy with product development and miss on the critical activity of documentation. However, per the requirements, if something is not documented it was never done. We help by working side by side of your design team and drafting, reviewing, and updating:


The requirement of clinical evidences is rising with the rise in innovation and the advent of new regulations. The question always remains as to how much data is enough? Amongst the various clinical services that Elexes has assisted with, the following have been the most important ones:

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