ISO 14971:2019 Section Document Section 5.2 (all; entries related to reasonably foreseeable misuse) 5.4 3 5.5 3, 4 6 3 7.1 4 7.2 4 7.3 4 7.5 4 IEC 62366-1:2015 Section Title Document Section 4.1.2 Risk Control as it relates […]
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1. Preliminary Remarks This document was prepared by the German Notified Bodies Alliance (“Interessengemeinschaft der Benannten Stellen für Medizinprodukte in Deutschland”, IG-NB) as a guide for Notified Bodies, manufacturers, and other interested parties. It is not intended to be comprehensive
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The Risk Management Plan outlines the risk policy and sets the criteria for risk acceptability. It also references relevant processes and activities integral to product-specific risk management within the integrated software development workflow (as detailed in SOP Integrated Software Development).
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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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