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Request For Quote (RFQ) – MDR Technical Documentation

Request For Quote (RFQ) - MDR Technical Documentation Please reach out to us with the details and we will provide you the solution. General and Manufacturer Information Please reach out to us with the details and we will provide you the solution. Scope of Work to be Undertaken by E & E Medicals Please provide…
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Full / Half Service – FDA 510(k) Request For Quote (RFQ)

Full/Half Service - FDA 510(k) Request For Quote (RFQ) Please reach out to us with the details and we will provide you the solution. General and Manufacturer Information Please reach out to us with the details and we will provide you the solution. Product Information Please provide with the details and we will provide you…
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US FDA Medical Device Registration

US FDA Medical Device Registration Please reach out to us with the details and we will provide you the solution. Establishment and Operation Please reach out to us with the details and we will provide you the solution. US Importer / Distributor Please reach out to us with the details and we will provide you…
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Free ISO 9001:2015 Gap Analysis Tool

Free ISO 9001:2015 Gap Analysis Tool Find out your level of compliance with ISO 9001. Please reach out to us with the details and we will provide you the solution. Context of the organization and Leadership Find out your level of compliance with ISO 9001. Please reach out to us with the details and we…
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Free ISO 13485:2016 Gap Analysis Tool

Free ISO 13485:2016 Gap Analysis Tool Find out your level of compliance with ISO 13485. Please reach out to us with the details and we will provide you the solution. Management Systems Find out your level of compliance with ISO 13485. Please reach out to us with the details and we will provide you the…
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EU MDR Technical Documentation

How to Start EU MDR Technical Documentation

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 […]
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ISO 14971 medical device risk management

ISO 14971 medical device risk management for medical devices

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 medical device […]
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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

Clinical data and postmarket compliance under the MDR

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 high standard of product quality. PMS is a regulatory requirement in major markets like Europe and the United States. Purpose of PostMarket compliance is to ensure […]
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