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EU MDR Technical Documentation / Gap Analysis/ Submissions Our experts review device design, risk analysis, clinical evaluation, testing reports, post-market surveillance, labeling, and other required areas. Gap analysis is carried out to ease the transition in the required areas. To meet with the New EU Medical Device Regulation (MDR) in which safety, efficacy, and performance […]

ISO 13485 medical quality system registration is an international standard adapted to meet the medical device industry’s requirements, and it addresses most FDA requirements (21CFR820). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused on ensuring medical devices safety and efficacy rather than enhancing customer satisfaction and continual […]

FDA Audit 483 Observations – US FDA Form 483 and Warning Letter Analysis FDA form 483 is officially known as Notice of Inspectional Observations. Organizations that act in non-conformity or violate GMP regulation/quality system are issued the FDA 483 warning Letter(s) by FDA investigators. Responding to FDA 483 warning Letter(s) deserves caution. An action plan […]

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 […]

FDA Applications In 1938, congress passed a set of laws giving authority to the U.S. Food and Drug Administration FDA application to oversee the safety of food, drugs, and cosmetics. Section 510(k) requires Medical Device manufacturers to register and notify FDA, at least 90 days in advance, of their intent to market a medical device […]

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 […]

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 […]

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 […]

Product Design Reliability Reliability Engineering, Risk & Productivity The FDA and other regulatory agencies do not regulate “reliability engineering” or “productivity” as standalone disciplines. Instead, they expect evidence that devices are reliable, risks are controlled, and processes are effective—and they enforce this through design controls, risk management, CAPA, and production controls. Reliability Engineering “Can you […]