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Medical device manufacturers rely on Enhanced Compliance to help bring their products to market.

One promising aspect of biomedical technology is the design and manufacturing of medical devices, from simple diagnostic equipment, to functional prosthetic limbs, to medical lasers.

Like the broader field, this burgeoning industry poses its own set of compliance challenges.

With rapidly changing technology in the hands of creative engineers, the possibilities for developing medical devices that can greatly improve the lives of many people are limitless.

Enhanced Compliance Inc. has worked closely with early adopters in this growing market, gaining experience to meet the compliance management and services needs of industry giants and emerging companies developing innovative new medical devices for market.

Compliance standards change as rapidly as today’s technology in the medical devices arena, and ECI-Rx has developed proven strategies and systems for development and manufacturing that ensure compliance with federal and global regulations.

We have the resources and know-how to work within aggressive time-to-market schedules common to this competitive industry.

EU MDR Expertise

New EU MDR regulations are to be approved in April 2017, with an expected 3- to 5-year implementation period.

These new requirements will impact every medical device and diagnostic device company who sells their products in EU.

All manufacturers will need to re-certify all their products against the new regulations. ECI-Rx can help navigate the complex flow of information review, audits, and testing needed to achieve certification.
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