ECI-Rx can help develop effective strategies for biotech companies that meet compliance regulations and often result in increased profits.
Advancing sciences and innovative technologies have created an emerging market for biotech that is on the verge of exponential growth potential. Enhanced Compliance Inc.’s consultants continually follow regulatory changes in this uncharted industry.
Our experienced biotech compliance experts are adept at instituting flexible systems and processes designed to manage compliance of diagnostic and therapeutic bio-engineered technologies.
Our team has formal training in bioengineering, giving us a unique perspective on our clients’ point of view in biomedical technology development, along with expertise on specific compliance management requirements and concerns in this developing field.
Innovative companies and their stockholders and investors gain peace of mind in working with ECI-Rx to manage their product compliance.
Our services have also proven to provide cost savings during the development phase, and may provide a competitive advantage once the product reaches the market. In addition, management efficiencies established in the early stages of product development can help to prolong product life.
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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, PMP
Project 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. Sheth
Vice 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. Ragonese
Sr. 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. Heffernan
Director 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.
J. Lane
Director, Endovascular Engineering and Product Development, Getinge Group, Maquet CardiovascularLearn how ECI-Rx can helpView our list of services