Sted Document Medical Device

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GHTF SG1 - Summary Technical Documentation …

https://www.imdrf.org/sites/default/files/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n063-2011-summary-technical-documentation-ivd-safety-conformity-110317.pdf

For Class A and B IVD medical devices, the STED will be prepared and submitted only at the request of a RA/CAB7 (see Figure 1). In this case, the manufacturer should be able to assemble and submit it in the timeframe indicated by the RA/CAB. The content of any …

Summary Technical Documentation (STED) for Demonstrating …

https://www.gmp-compliance.org/guidelines/gmp-guideline/summary-technical-documentation-sted-for-demonstrating-conformity-to-the-essential-principles-of-safety-and-performance-of-in-vi

Guideline Content: This document is intended to provide guidance on the content of the STED for IVD medical devices to be assembled and submitted, where applicable, to a …

Technical Documentation and Medical Device …

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

Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation. …

What is the STED format for medical device technical …

https://www.massdevice.com/what-is-the-sted-format-for-medical-device-technical-documentation/

Summary Technical Documentation (STED) was developed to drive more standardization of medical device regulatory submissions across markets. STED is …

Components of the STED or design dossier

https://www.tga.gov.au/resources/publication/publications/what-manufacturer-needs-know-about-conformity-assessment-and-declarations-conformity-ivds/components-sted-or-design-dossier

Device description. A detailed description of the IVD must be provided, including information addressing each of the following points: Intended purpose; Intended user; …

PROPOSED REVISED DOCUMENT - IMDRF

https://www.imdrf.org/sites/default/files/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n011r20-essential-principles-safety-performance-medical-devices-sted.pdf

The STED should include the following device descriptive information: a general description of the device including its intended use/purpose; the intended patient …

Contents of the STED for IVD - Regulatory and More

https://regulatoryandmore.com/2020/01/01/contents-of-the-sted-for-ivd/

The STED should include the following device descriptive information: a) the intended use of the IVD medical device. This may include: 1) what is detected 2) its …

STED Explained | RegDesk | Professional …

https://www.regdesk.co/sted-explained/

Summary Technical Document (STED) is the proposed harmonized format used for regulatory submissions by the Global Harmonization Task Force (GHTF). Albeit …

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 …

Sunglasses, Spectacle Frames, Spectacle Lens and …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/sunglasses-spectacle-frames-spectacle-lens-and-magnifying-spectacles

Guidance on importing medical devices into the U.S. is available at Importing into the U.S. If you need additional assistance, please call CDRH-Division of Industry and Consumer …

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