Business

ISO 14971 Medical Device Risk Management

ISO 14971 Medical Device Risk Management ISO 14971 compliance helps medical device manufacturers introduce safe medical devices into the marketplace by evaluating and controlling the risks associated with a medical device, and by evaluating a device’s interactions with other devices. As the only international standard for risk management for medical devices, ISO 14971 has become […]
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Pre-IDE Process

Pre-IDE Process An IDE is a regulatory submission that permits clinical investigation of devices. This investigation is exempt from some regulatory requirements. The name “Investigational Device Exemption” stems from this description in 21 CFR 812.1: “An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard […]
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Postmarket Compliance

Regulatory Post Market Surveillance Process It is called as medical device post-market surveillance (PMS), a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality. PMS is a regulatory requirement in major markets like Europe and the United States. The purpose of compliance is […]
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Canada License Applications

Health Canada Medical Device License (MDL) and MDEL Registration With more than 1000 medical device manufacturing facilities and a strong presence in the medical device market with about 60% of their imports coming from the United States and other regions of the world, all medical devices sold into the Canadian market must comply with Canadian […]
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ISO 13485 Medical Quality System Registration

ISO 13485 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 improvement. Appointing E& E […]
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FDA 483 Observations / Warning Letters / Recalls and Remediation

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 […]
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FDA US Agents 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 510(k), PMA, De Novo Submissions / Applications

FDA Applications In 1938, congress passed a set of laws giving authority to the U.S. Food and Drug Administration (FDA) 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 in […]
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FDA Establishment Registration

FDA Establishment Registration All establishments that produce and market medical devices in the United States have 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 an US FDA Agent with consultants supporting manufactures & distributors during the […]
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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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