Medical Device Technical File Guidance

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Recent Final Medical Device Guidance Documents | FDA

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents

Jan 12, 2023

MDR Documentation Submissions - BSI Group

https://www.bsigroup.com/globalassets/meddev/localfiles/en-gb/documents/bsi-md-mdr-best-practice-documentation-submissions-en-gb.pdf

conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI of (EU) 2017/745 Medical Devices Regulation …

Technical Documentation and Medical Device …

https://www.bsigroup.com/contentassets/c48f4dd0aa8d4042987a2fbe72c3e086/white_paper__technical_documentation_web_v3.pdf

Compiling the technical documentation Technical documentation has to be developed during the design and development process of a device and maintained throughout its …

Technical Documentation for Medical Devices - Johner …

https://www.johner-institute.com/articles/regulatory-affairs/and-more/technical-documentation/

Regulatory requirements for the technical documentation. a) Medical Device Directive …

Master Files | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/premarket-approval-pma/master-files

Introduction to Master Files for Devices (MAFs) A premarket approval application (PMA) or an investigational device exemption application (IDE) usually contains data and other …

Medical Device Technical File and Its Structure - SimplerQMS

https://www.simplerqms.com/medical-device-technical-file/

A medical device technical file is a mandatory technical document that your medical devices company will submit to the concerned regulatory authorities in the …

Medical Device Technical File Checklist: The Ultimate …

https://www.kolabtree.com/blog/medical-device-technical-file-checklist-the-ultimate-guide/

The essential Technical File checklist for medical device manufacturers. Download the one-page guide to make sure you’ve got everything you need to …

How to Structure your Medical Device …

https://www.greenlight.guru/blog/technical-file

The medical device technical file is a must-have document for devices to be sold in the EU marketplace. The file contains detailed information about your medical device, its …

Technical Documentation - MEDDEV

http://www.meddev.info/_documents/R2_5_1-5_rev4.pdf

The requirements for the technical documentation are laid down in the various An-nexes of the medical devices Directives, as appropriate for the conformity assess-ment …

Guidance documents – Medical devices - Canada.ca

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

Guidance for Industry: Device Licence Applications for Ultrasound Diagnostic Systems and Transducers [2013-09-13] Guidance Document: Guidance on supporting …

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