White Papers

    At Elexes we develop in-depth white papers on various regulatory, design control, clinical evaluations, quality systems, and compliance topics. These white papers are written to help the IVD and medical device companies understand the opportunities, steps, and potential solutions to everyday challenges they face. The content under this section can help you if you are looking to bring a new product to the market and seeking various regulatory approvals, or want to ensure there are no lawsuits or compliance problems around the products you have on the market.

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    Elexes Experts and the Team are continually looking to add value to the medical device and IVD companies they serve. These simple videos are around some important questions that companies often come across when gearing up to get their first product to the market and while sustaining the ones that are on the market. The intent of discussing both premarket and postmarket issues in these videos is to give you a comprehensive insight into topics that are common and topics that are uncommon, but critical.

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    News & Events

    Staying up to date with changing regulations and standards is a prerequisite for medical device and IVD companies. Learn about new and modified requirements by signing up for our news and events, take actions proactively rather than reactively for an upcoming surprise audit, FDA inspection, or due diligence that you might have to undergo for an investment into the company, distribution deals, etc. By staying current, our Clients have also been able to avoid lawsuits that could cost them millions of dollars. We stand by your side through all the changes, so you can stay in compliance.

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