{"id":600,"date":"2024-11-22T10:19:12","date_gmt":"2024-11-22T10:19:12","guid":{"rendered":"https:\/\/newmeden.sviluppokeyweb.com\/sistemi-di-gestione-per-la-qualita-e-di-gestione-del-rischio\/"},"modified":"2025-02-07T07:42:30","modified_gmt":"2025-02-07T07:42:30","slug":"quality-management-and-risk-management-systems","status":"publish","type":"page","link":"https:\/\/www.newmedconsulting.com\/en\/quality-management-and-risk-management-systems\/","title":{"rendered":"QUALITY MANAGEMENT AND RISK MANAGEMENT SYSTEMS"},"content":{"rendered":"

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A QUALITY PRODUCT IS ALSO A SAFE PRODUCT<\/h1>\n

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One of our goals is to support you in the design phase of your medical device<\/strong>, ensuring its compliance with all applicable standards and regulations, and assessed on the basis of all possible risks<\/p>\n

NewMed Consulting<\/strong> has over twenty years of experience in quality management consulting<\/strong>. This term refers to compliance with the ISO 13485<\/strong> and ISO 9001<\/strong> standards, which are internationally recognized reference standards for quality management systems.<\/p>\n

Risk management<\/strong> is essential in the design of a medical device<\/strong>. It is necessary to ensure that the device is produced only after careful assessment of the risks<\/strong> associated with its use, the potential harm it could cause, its severity and the probability that they may occur. We will assist you in the preparation of the Risk Management File<\/strong>, which concerns the processes implemented for risk management<\/p>\n

Contact us now and ask for a consultation!<\/strong><\/p>\n

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European Commission<\/p>\n

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EU Regulation 2017\/745 MDR<\/span><\/p>\n

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Italian Ministry of Health<\/p>\n

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type=”4_4″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”Roboto|300|||||||” text_text_color=”#ffffff” text_font_size=”42px” text_line_height=”1.2em” header_font=”–et_global_heading_font||||||||” header_text_color=”#000000″ custom_margin=”-12px||||false|false” custom_margin_tablet=”-22px||||false|false” custom_margin_phone=”-22px||||false|false” custom_margin_last_edited=”on|phone” hover_enabled=”0″ text_font_size_tablet=”” text_font_size_phone=”25px” text_font_size_last_edited=”on|phone” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

YOUR JOURNEY WITH US <\/strong><\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”||||||||” text_text_color=”#000000″ text_font_size=”15px” text_line_height=”1.5em” custom_margin=”1px||||false|false” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|phone” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

Designing and certifying a medical device requires knowledge and expertise<\/strong>, essential qualities that you can find in NewMed Consulting<\/strong>. Starting from your specific needs<\/strong>, we support you in the project through in-depth consultancy. After the implementation of the service<\/strong>, it is our duty to help you achieve the certification results<\/strong> required by law. We act in the certainty of satisfying your experience with us.<\/p>\n

To achieve all this, we are committed to continuous training that allows us to stay updated on new directives and ensure a professional and well-prepared service.<\/p>\n

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Would you like more information?
<\/strong>Contact us, our team is at your service.<\/p>\n

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Contact us<\/p>\n

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