Business

Quality Management System Implementation

ISO 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 quality […]
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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 System Regulation (QSR) Adherence to the FDA’s Quality System Regulation (QSR) is often the greatest challenge facing Medical Devices and Biotech manufacturers. The scope of QSR is large, and non-compliance is not an option. As a result, E & E Medicals and Consulting help companies to meet the needs of those responsible for compliance […]
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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 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 FDA’s Quality System Regulation […]
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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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ccc-mark-approval

Is CCC Mark Approval necessary for Medical Devices and IVD?

China Compulsory Certification (CCC) The CCC mark is the new compulsory Safety & Quality mark for many products sold on the Chinese market. CCC Mark Approval  became effective on May 1, 2002. It is the result of the recent integration of China’s two compulsory inspection systems. (One to check contents of products for import and […]
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Six Sigma – Healthcare

What is Six Sigma? Six Sigma is a process improvement initiative used to eliminate defects from processes. The goal is to create near perfection through continuous improvement that aligns the “voice of the process” with the “voice of the customer”. No more than 3.4 defects per one million opportunities (DPMO) is the goal of Six […]
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Reliability

Product Design E&E Medicals and consulting will help you carry design reviews to spot any major issues that will create obstacles to compliance testing. Test Plan Development To set reliability goals for your product, and make sure it meets that design at the prototype phase, our reliability experts design a test plan for you that ensures your […]
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