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If you’re looking for an engineering partner equipped to address your market challenges and help improve your processes long-term, we’d love the opportunity to support you.

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Client Testimonials

"What an amazing accomplishment! Thank you to the team and all who supported this effort! To pull this in as far as you did is outstanding! This will ensure submission of the product early next year and finish the last submission. Awesome job everyone."

Project Manager
"I cannot say enough great things about the ECI consultants. They are doing absolutely great work and adding a ton of value!"

Director, Global Product Marketing
"I would like to thank you all for being the leaders this program needs, exhibiting many elements of the company’s recognized 4 pillars of Leadership: Strategic, Collaborative, People, Performance."

R&D Manager
"This submission will ensure the product remains available to our patients for years to come. The team displayed continuous cross-functional collaboration, adaptability, and constant focus to achieve an on-time submission. Thank you to each team member for your hard work, and countless hours of dedication to achieve this great goal of submitting for EU MDR approval."

R&D Project Manager
“I am pleased to wholeheartedly recommend ECI consultants for their outstanding collaboration during our quality system implementation and remediation, audit preparation and readiness, as well as their pivotal role in our multi-site support endeavors across both the US and Europe. Their comprehensive regulatory knowledge, strategic insights, and meticulous audit groundwork have been integral to our achievement of compliance and enhanced credibility.”

Sr. Manager, Global Quality Systems
“ECI's steadfast presence on-site, their proactive approach to troubleshooting, and their ability to seamlessly align global and local practices have been fundamental to achieving consistently successful outcomes. Their enduring dedication and collaborative ethos render them an indispensable partner for any organization aspiring to excel in quality management systems and compliance with the regulations.”

Sr. Manager, Global Quality Systems
"This is a moment to reflect and thank you for your contribution to our integration’s core system and distribution “go live” project and for the extra effort you put in day in and day out to ensure a smooth transition. Your creativity and willingness to collaborate continuously set a high bar within the project team.”

Senior Technical Writer
“The value you’ve added to our business unit has helped us reach new levels of productivity, reach of customers, and stability.”

Senior Technical Writer
“This project would not have achieved its success without your involvement. You dove into the myriad and complex work of developing label specification and individual label files. Your organizational skills kept our labeling team members focused on our hundreds of deliverables across both work streams. Every week, your easy-to-read communication kept stakeholders focused on progress and aware of risks early. The education and teaching you gave raised the productivity of all team members.”

Senior Technical Writer
“This engagement is a sterling example of elevating our business, driving high performance through sharing knowledge, and empowering each other through collaboration across the business. Thank you again for your contributions and hard work."

Senior Technical Writer
"I give my full endorsement to the key attributes that ECI 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 the project lead on multiple devices ranging from urology to endoscopy; all work has passed multiple audits in the years since."

Sr. Process Development Engineer
"Based on their experience, ECI 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 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."

Director, Engineering and Product Development
"ECI has helped our company create key quality system policies and procedures. The ECI management is very collaborative, engaging, and responsive to our needs. They ensured that the work was managed effectively and efficiently."

VP of Corporate Quality
"We contracted with ECI 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 (MDD). 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 theECI team’s skills and knew I could always count on them for high quality deliverables."

Project Manager
“ECI was contracted to support a large remediation project. Thanks to Randy providing onsite project management, the additional quality system resources needed to address the issues were quickly defined. ECI was able to deploy many highly qualified consultants as requested. The entireECI team was professional, collaborative, and hard-working. The regulatory resources provided positive contributions on day one, given their valuable skillsets such as software development, engineering experience and a former FDA reviewer.”

Senior Director of Regulatory Affairs

Latin America Testimonials

“Thankful for the rapid actions implemented by ECI consultants.”

Senior Quality Manager
“ECI has become an essential supplier to the successful development of our start-up, performing a variety of critical functions at such a pivotal stage."

Engineering Quality Manager
“The performance and knowledge of your team is exceptional. From day one, ECI consultants have provided highly knowledgeable support and advice to our team. They have become indispensable sources of information as trusted SMEs to our staff.”

Supervisor & Project Manager
“Your support with the mock audits was indispensable and positioned us for a successful market entry into the medical device industry”

Director of Operations

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Our team has helped clients across the world address a variety of challenges and we want to partner with you too. Get in touch with our expert team today to get started.

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