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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, Quality System Regulation

ISO 14971 medical device risk management for medical devices

ISO 14971 Medical Device Risk Management Expert 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 […]
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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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Canada License Applications

How To Get Health Canada License Applications For MDL & MDEL

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

ISO 13485 Medical Quality System Registration for medical devices

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 […]
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FDA 483 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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