Enhanced Compliance Inc.

ECI provides consulting services in regulatory, quality and engineering specialties. ECI's Regulatory Affairs staff actively monitor and analyze publicly available resources to stay up to date on current regulatory requirements. Current regulatory intelligence helps to provide sound rationale for the applicable requirements for a specific project. Consults define the scope of regulatory oversight to ensure all applicable entities are defined (i.e., FDA, ONC, SEC, state law, Competent Authorities etc.) to ensure compliance. ECI provides an assessment of its clients Quality Management System for conformance to requirements to identify potential areas of improvement. Depending on a client's need, ECI can establish and implement a new Quality Management System or provide targeted recommendations to address a specific area of non-conformance. Consultants conduct mock audits to mirror a regulatory agencies sampling of company records used to support product safety and effectiveness. A mock audit can help determine preparedness for inspection and identify areas for training. There are several ways a consultant supports the monitoring of a devices' performance in the market to ensure product safety, efficacy, and compliance. Consultants can provide quick access to timely data surrounding the industry’s total product lifecycle of a particular device. This will help a manufacturer recognize market signals when reviewing their own technology and complaint handling records. Consultants can ensure the clients Quality Management System is robust, that its procedures contain required elements to effectively address Complaint Handling and Medical Device Reporting as well as feedback into the required activities for risk management, clinical evaluation, and post-market review processes. When applicable, ECI can augment existing staff resources to ensure timely complaint handling and medical device reporting per the regulation. ‍ECI provides training programs tailored to meet the specific needs of its client. Examples of typical training programs include: Complaint handling Medical device reporting Implementing effective Corrective and Preventive Action Implementing an effective recall program Preparing for agency inspection Other Quality Management System elements Enhanced Compliance is not a staffing organization. How does ECI help a company obtain market access? Our regulatory team can define an appropriate regulatory strategy using the applicable regulations and guidance’s based on the client’s strategic business requirements and timeline. The ECI team can provide an assessment of the company’s Quality Management System and its conformance to design controls to ensure an efficient regulatory submission process. Consultants prepare the client to interact with regulatory agencies at the appropriate time, to obtain feedback prior to the submission of a marketing application. Our services include writing, assembling, reviewing or support to submission preparation, responding to agency requests for information throughout the review process to obtain 510(k) clearance, PMA (Premarket Approval) or a license is granted.

Consulting services can be a cost-effective way to address an immediate need within an organization. Consultants enter your organization fully trained in the area of need and can support developing the same skills within your own team or simply free up your team to work on other business priorities. Consultants can be used to bridge a resource deficit while your internal talent acquisition team searches for the ideal candidate to fill the void. Consultants provide a unique perspective to challenges as they have experienced similar issues at other organizations and clients. Finally, consultants are available for all lengths of engagements, giving you flexibility to scale up and down as budgets allow. ECI provides consultants in many subject areas but, as a project management office (PMO) based organization, offers individualized management of all your resource and project needs as well.