{"product_id":"iso-14971-2019-medical-device-risk-management-system","title":"ISO 14971:2019 Medical Device Risk Management System","description":"\u003cp\u003e\u003cem\u003eAn editable risk management system for medical devices and IVDs, built on ISO 14971:2019 and usable for any device class or technology.\u003c\/em\u003e\u003c\/p\u003e\n\u003ch2\u003eOverview\u003c\/h2\u003e\n\u003cp\u003eA risk management file has to hold together from intended use to post-production. Each hazard leads through a hazardous situation to a harm, each risk is estimated and evaluated against your own criteria, and each control is verified for both implementation and effectiveness. This system keeps that chain intact. Its master risk register calculates risk regions and names the first missing link in each chain.\u003c\/p\u003e\n\u003cp\u003eIt follows ISO 14971:2019 practice closely. Hazard, hazardous situation and harm stay separate, no risk matrix is imposed, detectability plays no part in estimation, and FMEA, FTA, HAZOP and similar methods are placed as supporting tools. ISO\/TR 24971:2020 is used as guidance, with a matrix that records how each part was applied. The system works inside an ISO 13485:2016 quality management system and links to Regulation (EU) 2017\/745 (MDR) and Regulation (EU) 2017\/746 (IVDR). Documentation alone does not demonstrate conformity, and no ISO 14971 certification scheme is implied. Regulations are referenced by citation. Standards are referenced by number and title only, and no standard text is included.\u003c\/p\u003e\n\u003ch2\u003eWhat this system covers\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eGovernance:\u003c\/strong\u003e a risk management policy, master procedure, governance charter, team terms of reference, roles, RACI and competence matrices, a training plan, performance indicators and escalation.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePlanning:\u003c\/strong\u003e a device risk management plan template, intended use and intended purpose statements, user, patient and environment profiles, and development of acceptability criteria.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAnalysis:\u003c\/strong\u003e device characteristic assessments, hazard identification and analysis worksheets, and templates for design, process and use FMEA, FTA, HAZOP, bow-tie and event tree analysis.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEvaluation and control:\u003c\/strong\u003e risk estimation and evaluation, risk control with separate implementation and effectiveness verification, residual risk and benefit-risk analysis, and the risk management review and report.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduction and post-production:\u003c\/strong\u003e collecting and reviewing information, and maintaining the risk management file when things change.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConditional modules:\u003c\/strong\u003e software, connected devices and cybersecurity, usability, biological safety, electrical equipment, and sterile, reusable, implantable and in vitro diagnostic devices, each naming the relevant device standards such as IEC 62304, IEC 62366-1, ISO 10993-1 and IEC 60601-1.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAssessment:\u003c\/strong\u003e ISO 14971 and ISO\/TR 24971 matrices, an EU MDR Annex I matrix, a gap assessment with 30-day, 60-day and 90-day plans, internal audit and management review.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eWho it's for\u003c\/h2\u003e\n\u003cp\u003eLegal, start-up and contract manufacturers, device designers, software as a medical device developers, and medical electrical equipment and IVD manufacturers. Within them, quality, regulatory, risk, design, clinical, post-market surveillance and complaint teams use it, together with internal audit and consultants.\u003c\/p\u003e\n\u003cp\u003eIt pairs with the ISO 13485:2016 medical QMS toolkit, which provides the quality management system that risk management operates within. For enterprise risk rather than device risk, see the ISO 31000:2018 risk management toolkit.\u003c\/p\u003e","brand":"Apex Global Solutions AGS","offers":[{"title":"Default Title","offer_id":57395092521300,"sku":"AGS-09-017","price":590.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1052\/4996\/4372\/files\/AGS-09-017.png?v=1790973347","url":"https:\/\/agskits.com\/products\/iso-14971-2019-medical-device-risk-management-system","provider":"Apex Global Solutions","version":"1.0","type":"link"}