Medical Device Change Notification

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Deciding When to Submit a 510(k) for a Change to an …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device

This document supersedes FDA’s guidance Deciding When to Submit a 510 (k) for a Change to an Existing Device (K97-1), issued on January 10, 1997. This guidance is not intended to implement ...

Definitive Guide to Change Management for Medical …

https://www.greenlight.guru/blog/change-management-medical-devices

Change Control Process : An Overview of …

https://www.qualitymeddev.com/2021/01/29/change-control/

An efficient change control process is nowadays essential for any Quality Management System within a regulated environment and both FDA and EU …

MDR - Guidance on Significant Changes for …

https://decomplix.com/medical-device-significant-changes/

For devices other than Class I, the changes and their implementation will be verified by the Notified …

MDR Significant Changes for Medical …

https://bioregservices.com/blog/mdr-significant-changes/

Verification of Changes Non-Class I devices. Notified Bodies will verify changes and their implementation for devices other than Class I, at audits or upon change …

HSA | Guidance documents for medical devices

https://www.hsa.gov.sg/medical-devices/guidance-documents

Guidance documents for medical devices. Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory …

Reporting Changes to the Notified Body - BSI Group

https://www.bsigroup.com/meddev/LocalFiles/en-IN/Events/UK-Consultants-Day-2015/BSI-md-consultants-day-reporting-changes-to-your-notified-body-presentation-UK-EN.pdf

the changes proposed… Annex V & VI Section 3 . The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to …

Guidance on Change Notification - Health Sciences …

https://www.hsa.gov.sg/docs/default-source/announcements/regulatory-updates/gn-21-r4-7-guidance-on-change-notification-for-registered-md(2dec)-for-consult.pdf

• Change to the intended purpose of a registered medical device; • Change to the risk classification of a registered medical device; • Addition of model(s) that do not fulfil the …

Notification of Substantial changes - TUV

https://www.tuv.com/content-media-files/master-content/global-landingpages/medical-device-testing-and-auditing/(s)cn_product-assessment-(ms-00368701).docx

Please provide brief summary about your evaluation of manufacturers information and recommendation(s) for further activities how to handle the notification. Activities might …

Guidance for the Interpretation of Significant Change of a …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-interpretation-significant-change-medical-device.html

No, this is not a significant change: Programmable Medical Device: A change in the operating system version (e.g. Service Pack 1 to Service Pack 2), but the …

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