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:
Medical device development end to end
Medical device development is a comprehensive series of well-coordinated activities and events from the moment of product concept and ideation, to risk assessment...
Looking for an ISO 13485 Certification?
Quality is the most important criterion to be fulfilled by medical device manufacturers to satisfy customers. Medical devices have an impact on t...
Best regulatory and quality consulting firm for medical devices, IVDs, and software in India and US
Ever since the boon of the healthcare industry as one of the largest industries in the world market, multiple medical device companies have been designing and developing devices that are enhanci...