Whether you’re just getting started and need help in understanding and implementing the FDA’s Quality System Requirements (QSRs) or you’re well established and need some additional expertise we can provide that support. We can also help you to move to the next step in pursuing ISO 13485. We will help you find the balance that is right for your organization to comply and still meet your operational requirements.

Not finding that balance can be costly in both directions. If you aren’t complying, you are putting your organization and the patients using your products at risk. If you put in a quality system that not only meets the requirements, but places a significant burden on operations than it adds significant costs. We can provide the expertise needed to help you make these decisions.

Complete Quality System Development & Implementation
We will assist you in meeting the FDA’s Good Manufacturing Practices (cGMPs) - 21 CFR Part 820 (Quality System Requirements) from complete quality system set-up to providing guidance in addressing what needs to be improved.

Auditing Services – Compliance Audits (FDA), Supplier Audits
Our auditing services will allow you to quickly identify where your or your supplier’s gaps exist, matching requirement to gap. We can also help you take the next step in moving towards ISO 13485.

Validation, Commissioning & Qualification Services
ECL2 is the U.S. preferred provider for validation services for those seeking validation of their automated quality management system. Please click here for more on automated quality management systems. In addition to providing system validation and ensuring compliance with 21 CFR Part 11, we also provide complete process validation as well as commissioning and qualification services for your equipment. Please contact us with your specific needs.

General Compliance Consulting
We are happy to assist you with all of your regulatory concerns whether its registering your facility or submitting a device listing with the FDA.

ECL2 worked with our general contractor, designing the manufacturing and warehousing space, worked with Sheri Gay, the President of Aero-Med Medical  to establish operations and hire the right personnel, took care of our regulatory requirements, implemented a new quality system, trained personnel and even acted as a liaison with our current and prospective client-base as we expanded our operation.
- Dan Del Mastro, Chief Executive Officer, Aero-Med Ltd.