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FDA United States Agent

FDA United States Agent for Foreign Establishments

US Agent for Foreign Establishments In adverse events under the Medical Device Reporting regulation (21 CFR Part 803) or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E), the United States Food and Drug Administration (FDA) requires all medical devices, IVD, and pharmaceutical companies not located (foreign facility) in the United States to appoint […]
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FDA Regulatory Intelligence | E & E Medicals & Consulting

US FDA Establishment Medical Device | An Overview

FDA Establishment Registration FDA Establishment that produces and markets medical devices in the United States has to follow a registration process with the FDA called “Establishment registration” within 30 days of commercialization of the medical device. E & E Medicals and Consulting is a US FDA Agent with consultants supporting manufactures & distributors during the […]
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ISO 9001 Quality Management System Implementation

ISO 9001 Quality Management System (QMS) Implementation E & E Medicals and Consulting’s quality management experts have been developing and implementing quality systems including ISO 9001 quality management system in companies attempting their first products approved by the FDA. We help in designing smart QMS that streamline business demands and increase practical time usage on […]
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Regulatory Strategy

Regulatory Strategy E & E Medicals and Consulting aims at facilitating product clearance or approval procedure with relative considerations of the current regulatory environment. Our global regulatory consultants develop strategies that provides confidence in forecasting key objectives with a clear plan of action. We also take into consideration the relevant guidelines, ongoing FDA and other […]
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Quality System Regulation (QSR)

Quality Management System Regulation (QMSR) The Quality Management System Regulation (QMSR) refers to the U.S. The FDA’s new rules for medical device makers (21 CFR Part 820) now include the international standard ISO 13485 and replace the old Quality System Regulation (QSR). The QMSR mandates a unified quality system that blends ISO 13485’s global best […]
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Audits

Quality Assurance Audits To maintain quality system, it is essential that you carry on routine quality assurance audits to eliminate the reduction in product quality, improve processes, eliminate loss of third party certifications of FDA enforcement. Three Different Types of Quality Assurance Audits ISO 9001 defines an audit as a “systematic, independent and documented process […]
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Medical Devices

Medical Devices Quality Assurance Medical Devices Quality Assurance Most medical device companies understand the risks of developing and mass-producing their products. However, many of these companies are not aware how to combat these risks effectively and efficiently. It is possible to experience the peace of mind that comes with employing a trusted medical device. The […]
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Other Countries

Other Countries Most companies require registration and approval from regulatory agencies in each country in which they plan to sell their products for the commercialization of their medical devices. The specifications of product registration vary considerably for every country, creating enforcement challenges for multiple market strategy companies. Valid registration, depending on where you intend to […]
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CE mark Approval

Best CE mark approval for medical devices consultants | An Overviews

CE Mark Approval The CE marking (known as CE mark) is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met the requirements of the applicable European Medical device derivative. Like active implantable medical device (AIMD) Directive 90/385/EEC […]
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