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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Requirement Mapping Medical Device Regulation (MDR) Document Section Annex VIII (All) Associated Documents: Intended Use SOP Product Certification and Registration Overview Product: (Enter content) Version: (Enter content) Classification: (Enter content) Rule: (Enter content) Justification for classifying the product as a
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EC Declaration of Conformity Manufacturer \ \ Medical Device \ \ \ Classification Medical Device Class: \ Classification determined in accordance with \. Reference Art. 51 MDR, Section 1, to identify the applicable classification rule. These are detailed in Annex
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Essential Requirements MDD (93/42/EEC) This document addresses all essential requirements outlined in Annex I of the MDD. Unlike other templates, the quoted sections below directly reference the MDD, without added explanations. These excerpts represent legal text from the MDD itself,
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