Medical Devices Industry | ECI | Enhanced Compliance Inc.

We're Agile.

We understand the unique challenges and are able to formulate comprehensive strategic solutions.

We're Experienced.

We have broad industry experience helping with products from simple disposable devices, to diagnostic devices and functional prosthetics, to high-tech medical lasers.

We're Informed.

We maintain a deep and extensive understanding of compliance standards as they relate specifically to your market.

We're Efficient.

We work effectively with critical project timelines to ensure safe products at all stages of the product lifecycle, from research & development through end-of-life.

When You Succeed, We Succeed.

The quality of our work establishes trust and paves the way for enduring, productive partnerships. Discover what ECI customers have to say about their experiences with us.

"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 EUMDR 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

"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.”

Sr. 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

"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

"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 & Product Development

“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 entire ECI 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.”

Sr. Director of Regulatory Affairs

Strategic Consulting for the Medical Devices Industry

Our Strategic Solutions

FDA Warning Letter

EU MDR

IVDR

Regulation Strategy & Submissions

Technology Transfer

Post Market & Resources Management

Merger & Acquisitions and Due Diligence & Integrations Solutions

When You Succeed, We Succeed.

Impact That’s Tangible

Medical Devices Case Study

Medical Devices Case Study

Medical Devices Case Study

Medical Devices Case Study

Medical Devices Case Study

Medical Devices Case Study

Other Industries We Serve

Biotech

Pharmaceutical

Nutritionals

Cosmetics

Pharmaceutical

Biotech

Nutritionals & Dietary Supplements

Cosmetics

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