Purpose: The Guidelines for Data Annotation detail how datasets should be annotated by medical experts to apply the labels necessary for training a machine learning model. They establish a standardized annotation style, defining both the accuracy and format of annotations. […]
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IEC 62304 requires the documentation of SOUP, which stands for Software of Unknown Provenance. In simpler terms, these are third-party libraries integrated into your code, often listed in files such as requirements.txt or Gemfile. Classes IEC 62304:2006 Section Document Section
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Regulation / Guidance Document Section Medical Device Regulation, Annex IXChapter II Section 4.10 All MDCG Guidance Document 2020-03 All Overview: This record is designed for documenting the evaluation of routine change requests as part of the company’s change management process.
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1. Regulatory References Applicable Regulations: IEC 62304, paras. 5.3.1 and 5.3.2 [classes B, C] Related Documentation: SOP Software Development User and stakeholder requirements Design input and software specifications (…) 2. Software Systems In line with DIN EN 62304, our software
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Applicable Regulations Document Section IEC 62304, Chapter 9 All Overview This record serves to document the assessment and execution of all bug fixes following the company’s change management procedure. Bug Fix Documentation Evaluation Criteria Bug ID #B01 #B02 (…) Description
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1. General Information This Standard Operating Procedure (SOP) outlines the approach we use for developing, training, and updating machine learning (ML) models for integration into our medical devices. Adhering to this process helps ensure that ML models are deployed and
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This document outlines your user needs, also known as “stakeholder requirements.” These form the initial stage of requirements mapping and represent the highest level of design input. Describe the broad requirements that your device must fulfill. Subsequently, these user needs
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This document outlines the activities related to development and maintenance. Correlation of Standard Requirements to Document Sections ISO 13485:2016 Section Document Section 7.3.2 Design and Development Planning 1, 2, 3, 7 Classes IEC 62304:2006 Section Document Section A, B, C
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Regulatory References ISO 13485:2016 4.2.3 ISO 20417:2021 All User Manual [Insert Product Name] Version: [Insert Content] Date: [Insert Content] [Placeholder for Company Address] Email: [Insert Content] Website: [Insert Content] [Placeholder CE Sign] [Placeholder UDI] [Insert Product Name] is a Class
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Mapping of Requirements to Document Sections MDR Class MDR Section Document Section (All) Annex II, 1.1 a) – d), h), i) (All) ISO 14971:2019 Section Document Section 5.2 (All) IEC 62366-1:2015 Section Document Section 5.1 (All) Product Information Name: \
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