Regulatory References: Regulation / Standard Description EU Regulation 2017/745 (MDR) Articles 87 and 89 (Incident analysis, vigilance, field safety corrective actions) ISO 13485:2016 Section 8.2.3 German Medical Devices Law (MPDG) Chapter 5, Articles 71–83 German Medical Device EU Adjustment Ordinance […]
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This template is intended for documenting the outcomes of post-market clinical follow-up (PMCF) activities for the [name of the medical device]. Note: As per MDR, Annex XIV, Part B (7), the manufacturer is required to analyze the PMCF findings and
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Summary This SOP outlines the procedure for managing serious incidents and field safety corrective actions (FSCA), as well as the reporting obligations to relevant authorities. Process Owner \ Key Performance Indicators \ Regulatory references: EU Regulation 2017/745 (MDR) Art. 87
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This template is specifically relevant for German medical device manufacturers, as the position of a Medical Device Consultant is defined by German Medical Device Legislation (§ 83 MPDG / § 31 MPG). Full Name Role/Team/Position Medical Device Date of Last
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(Insert Company Name) Field Safety Notice for (Insert Product Name and Version Number) (Date) Please note: This Field Safety Notice (FSN) must be presented in the official language(s) of the country where the device is being used. Translation may be
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Overview This SOP outlines the process for carrying out Post-Market Surveillance (PMS) for products. It ensures the proactive collection of new safety and performance information, which is then used to support risk management, clinical evaluation, and software development processes for
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This template is intended to provide a guideline for structuring your training records. It is recommended to use Excel or Sheets rather than Microsoft Word for better data management. Consider this as having two separate sheets – one for initial
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This table aligns the ISO 13485:2016 requirements by section with the corresponding documents. The document titles listed in the “Fulfilled in Document” column are based on FdaToday templates. If you use a different system for naming documents, feel free to
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This plan outlines product-specific post-market surveillance activities. The general procedures for conducting post-market surveillance are described in the SOP Post-Market Surveillance, with outputs documented in the Post-Market Surveillance Report or the Periodic Safety Update Report. Regulatory References: EU Regulation 2017/745
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Regulatory Requirement Document Section MDR Annex I (General Safety and Performance Requirements), Annex IV (EU Declaration of Conformity), Art. 27, 29, 31 (UDI / Eudamed) All MPDG §8, §96, §97 All ISO 13485:2015, Sections 4.2.3 All Overview This SOP outlines
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