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.
Read More on EU MDR
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“High Quality Deliverables”
We contracted with ECI-Rx for a multi-year, multi-million-dollar remediation effort focused on updating existing commercially available products to meet state-of-the-art requirements per the Medical Device Directive.
Randy oversaw both project management (budgeting, resource planning and scheduling), as well as technical elements (specification development, test method/validation and risk management), managing day-to-day activities and strategizing with Senior Management.
I developed a strong appreciation for the ECI-Rx team’s skills and knew I could always count on them for high quality deliverables.
M. Adams, MBA, PMPProject Manager, Endoscopy Sustaining Engineering, Boston Scientific Corporation
“Responsive to our needs”
ECI-Rx has helped our company create key Quality System policies and procedures. The ECI-Rx management is very collaborative, engaging and responsive to our needs. They ensured that the work was managed effectively and efficiently.
V. ShethVice President, Corporate Quality, Medtronic
“Eager to do things right the first time”
I give my full endorsement to the key attributes that ECI-Rx will bring to your organization. Specifically, their knowledge, professionalism, drive, quality of work and eagerness to do things right the first time will add value to your impending project needs.
Brijesh and Shital were project leads on multiple devices ranging from urology to endoscopy; they remediated well over 1000 finished good codes combined over the course of 2 years. All work has passed multiple audits in the years since.
T. RagoneseSr. Process Development Engineer, Boston Scientific Corporation
“Technical abilities are outstanding”
Randy, who served as project manager, is very skilled in all aspects of the quality system, with deep understanding of medical device requirements. His strong engineering skills and ability to mentor younger engineers was key to our overall success.
Brijesh and Shital both led specific elements under Randy’s leadership supporting our program. Their technical abilities are outstanding. Each of the 200+ projects within the program had upwards of 50 individual deliverables to meet the overall requirements. The team oscillated well between the multiple design elements, with the goal of meeting the final deliverable.
K. HeffernanDirector of Quality, Corporate Steward, Post Market Processes, Boston Scientific
“Professional & Experienced”
Based on their experience, ECI-Rx recommended placing on-site managers to assist with activities and personnel which eased the added strain on our full-time managers due to the number of contracted resources.
I would not hesitate to use ECI-Rx for future projects; I found their professionalism and depth of resources was second to none. We succeeded in completing our mission and owe a great deal of the success to Enhanced Compliance.