{"id":13848,"date":"2022-02-16T15:26:08","date_gmt":"2022-02-16T14:26:08","guid":{"rendered":"https:\/\/www.echolightmedical.com\/?p=13848"},"modified":"2023-05-03T15:19:36","modified_gmt":"2023-05-03T13:19:36","slug":"new-quality-standard","status":"publish","type":"post","link":"https:\/\/www.echolightmedical.com\/en\/new-quality-standard\/","title":{"rendered":"New quality standard"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; admin_label=&#8221;Sezione&#8221; _builder_version=&#8221;4.16&#8243; height=&#8221;400px&#8221; custom_margin=&#8221;0px|0px|0px|0px|false|false&#8221; custom_padding=&#8221;0px|0px||0px|false|false&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_color=&#8221;#ffffff&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_post_title title=&#8221;off&#8221; meta=&#8221;off&#8221; featured_placement=&#8221;background&#8221; _builder_version=&#8221;4.16&#8243; title_font=&#8221;|600|||||||&#8221; title_text_align=&#8221;left&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;rgba(255,255,255,0) 0%|#ffffff 100%&#8221; background_color_gradient_start=&#8221;rgba(255,255,255,0)&#8221; background_color_gradient_end=&#8221;#ffffff&#8221; parallax=&#8221;on&#8221; parallax_method=&#8221;off&#8221; custom_margin=&#8221;0px|0px|0px|0px|false|false&#8221; custom_padding=&#8221;0px|0px|0px|0px|false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_fullwidth_post_title][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;100px|0px|0px|0px|false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; text_font_size=&#8221;16px&#8221; header_font=&#8221;|600|||||||&#8221; header_text_align=&#8221;left&#8221; header_font_size=&#8221;32px&#8221; header_2_text_align=&#8221;left&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; header_text_align_tablet=&#8221;&#8221; header_text_align_phone=&#8221;&#8221; header_text_align_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Echolight is pleased to announce that a new process to improve the company organization has been successfully completed, this time aimed at internationalization<\/h2>\n<p>&nbsp;<\/p>\n<p>In the first weeks of 2022, the international body DQS Medizinprodukte GmbH based in Frankfurt am Main (Germany) issued the MDSAP (Medical Device Single Audit Program) certificate to Echolight Spa.<\/p>\n<p>It is one of the most recent quality standards for the electro-medical sector and specifically concerns the definition of the requirements of the quality management system of companies that design and manufacture medical devices.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>A single audit for medical devices<\/strong><\/h3>\n<p>&nbsp;<\/p>\n<p>The MDSAP program allows the bodies accredited by the Regulatory Authorities of the five participating countries to carry out a single audit aimed at verifying that the equipment produced meets the management requirements of the Quality System of the reference countries.<\/p>\n<p>The audit was conducted on the basis of accredited procedures and certified that the Apulian company has implemented an adequate Quality Management System (QMS), with specific reference to the sector of ultrasound medical devices and related quantitative and qualitative diagnostic software, analysis of the musculoskeletal system and multispecialistic applications.<\/p>\n<p>This is the detail of the participating agencies:<\/p>\n<ul>\n<li>AUSTRALIA &#8211; Australia Therapeutic Goods Administration of Australia (TGA)<\/li>\n<li>BRAZIL &#8211; Ag\u00eancia Nacional de vigil\u00e2ncia sanit\u00e1ria (ANVISA)<\/li>\n<li>JAPAN &#8211; Japanese Ministry of Health, Labor and Welfare (MHLW)<\/li>\n<li>CANADA &#8211; Health Canada (HC)<\/li>\n<li>USA &#8211; Food and Drug Administration (<a href=\"https:\/\/www.fda.gov\/\">FDA<\/a>)<\/li>\n<\/ul>\n<p>This opens up a further international scenario for the company.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>A palmares of certificates<\/strong><\/h3>\n<p>&nbsp;<\/p>\n<p>MDSAP is the latest recognition in order of time that is combined with a very well structured quality system.<\/p>\n<p>To date, Echolight holds the following certifications (all issued by Kiwa Cermet Italia):<\/p>\n<ul>\n<li>ISO 9001: 2015 which is the basic standard for the regulation and systematization of company management procedures;<\/li>\n<li>ISO 13485: 2016 which expressly concerns companies that design and produce electro-medical devices, ascertaining their quality and safety requirements. The standard is in fact a precondition for the CE mark and also for the just obtained Medical Device Single Audit Program.<\/li>\n<\/ul>\n<p>These are the different organizational areas that <a href=\"https:\/\/www.echolightmedical.com\/\">Echolight<\/a> has certified on the basis of the ISO 13485 standard:<\/p>\n<p>&#8211; the design,<\/p>\n<p>&#8211; Development,<\/p>\n<p>&#8211; production,<\/p>\n<p>&#8211; distribution,<\/p>\n<p>&#8211; installation,<\/p>\n<p>&#8211; technical support.<\/p>\n<ul>\n<li>CE mark (in compliance with Directive 93\/42 \/ EEC): it certifies that medical devices comply with a series of essential requirements for being placed on the Community market. These include the safety and protection of the patient and operator, as well as the protection of the environment.<\/li>\n<\/ul>\n<p>We will go further. Ad maiora semper.<\/p>\n<p>[\/et_pb_text][et_pb_divider color=&#8221;#e3e3e3&#8243; divider_position=&#8221;bottom&#8221; _builder_version=&#8221;4.16&#8243; module_alignment=&#8221;center&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; background_enable_color=&#8221;off&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;#fff 0%|#f3f3f3 100%&#8221; background_color_gradient_start=&#8221;#fff&#8221; background_color_gradient_end=&#8221;#f3f3f3&#8243; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;||250px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_blog fullwidth=&#8221;off&#8221; 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type=\"text\/javascript\">\ndocument.addEventListener( 'wpcf7mailsent', function( event ) {\nlocation.href =\"\/en\/thankyou-page\";\n}, false );\n<\/script>\n<div class=\"form_contatti\">\n  <div class=\"text_contact\">\n      <p class=\"p1\">Contact Us<\/p>\n      <p class=\"p2\">More info or book a demo.<\/p>\n   <\/div>\n  <div class=\"form_container\">\n    <div class=\"column\">\n      <span class=\"wpcf7-form-control-wrap\" data-name=\"firstname\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required nome\" id=\"firstname\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Name*\" value=\"\" type=\"text\" name=\"firstname\" \/><\/span>\n      <span class=\"wpcf7-form-control-wrap\" data-name=\"lastname\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required cognome\" id=\"lastname\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Surname*\" value=\"\" type=\"text\" name=\"lastname\" \/><\/span>\n      <span class=\"wpcf7-form-control-wrap\" data-name=\"email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email email\" id=\"email\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"E-mail*\" value=\"\" type=\"email\" name=\"email\" \/><\/span> \n      <p class=\"radio_e\" style=\"margin-bottom:5%\">Position* <span class=\"wpcf7-form-control-wrap\" data-name=\"Type\"><span class=\"wpcf7-form-control wpcf7-radio posizione\" id=\"Type\"><span class=\"wpcf7-list-item first\"><label><span class=\"wpcf7-list-item-label\">Distributor<\/span><input type=\"radio\" name=\"Type\" value=\"Distributor\" checked=\"checked\" \/><\/label><\/span><span class=\"wpcf7-list-item\"><label><span class=\"wpcf7-list-item-label\">Doctor<\/span><input type=\"radio\" name=\"Type\" value=\"Doctor\" \/><\/label><\/span><span class=\"wpcf7-list-item last\"><label><span class=\"wpcf7-list-item-label\">Patient<\/span><input type=\"radio\" name=\"Type\" value=\"Patient\" \/><\/label><\/span><\/span><\/span><\/p>\n      <div data-id=\"group-51\" data-orig_data_id=\"group-51\" data-clear_on_hide class=\"\" data-class=\"wpcf7cf_group\">\n      <span class=\"wpcf7-form-control-wrap\" data-name=\"medical_specialty\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required selezione\" id=\"medical_specialty\" aria-required=\"true\" aria-invalid=\"false\" name=\"medical_specialty\"><option value=\"\">Clinical specialty*<\/option><option value=\"Allergology\/Immunology\">Allergology\/Immunology<\/option><option value=\"Anesthesia and Resuscitation\">Anesthesia and Resuscitation<\/option><option value=\"Cardiology\">Cardiology<\/option><option value=\"Clinical Physiology\">Clinical Physiology<\/option><option value=\"Dermatology\">Dermatology<\/option><option value=\"Endocrinology\">Endocrinology<\/option><option value=\"Epidemiology\">Epidemiology<\/option><option value=\"Gastroenterology\">Gastroenterology<\/option><option value=\"General Practice\">General Practice<\/option><option value=\"Geriatry\">Geriatry<\/option><option value=\"Gynecology\">Gynecology<\/option><option value=\"Health Fitness\">Health Fitness<\/option><option value=\"Internal Medicine\">Internal Medicine<\/option><option value=\"Neurology\">Neurology<\/option><option value=\"Neurosurgeon\">Neurosurgeon<\/option><option value=\"Nuclear Medicine\">Nuclear Medicine<\/option><option value=\"Nurse\">Nurse<\/option><option value=\"Nutritionist\">Nutritionist<\/option><option value=\"Oncology\">Oncology<\/option><option value=\"Orthodontics\">Orthodontics<\/option><option value=\"Orthopaedics\">Orthopaedics<\/option><option value=\"Osteopathy\">Osteopathy<\/option><option value=\"Otorhinolaryngology\">Otorhinolaryngology<\/option><option value=\"Pediatrics\">Pediatrics<\/option><option value=\"Pharmacy\">Pharmacy<\/option><option value=\"Physiatry\">Physiatry<\/option><option value=\"Physiotherapy\">Physiotherapy<\/option><option value=\"Podiatry\">Podiatry<\/option><option value=\"Psychiatry\">Psychiatry<\/option><option value=\"Radiology\">Radiology<\/option><option value=\"Radiology Technician\">Radiology Technician<\/option><option value=\"Researcher\">Researcher<\/option><option value=\"Rehabilitation\">Rehabilitation<\/option><option value=\"Rheumatology\">Rheumatology<\/option><option value=\"Sport Medicine\">Sport Medicine<\/option><option value=\"Surgeon\">Surgeon<\/option><option value=\"Traumatology\">Traumatology<\/option><option value=\"Urology\">Urology<\/option><option value=\"General Practicioner\">General Practicioner<\/option><option value=\"Academic\">Academic<\/option><\/select><\/span>\n      <\/div>\n      <p class=\"campi\">*Required fields<\/p>\n    <\/div>\n    <div class=\"column ml\">\n      <span class=\"wpcf7-form-control-wrap\" data-name=\"region\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required regione\" id=\"region\" aria-required=\"true\" aria-invalid=\"false\" name=\"region\"><option value=\"\">Choose Area*<\/option><option value=\"Europa\">Europa<\/option><option value=\"Middle East Asian\">Middle East Asian<\/option><option value=\"Latin America\">Latin America<\/option><option value=\"USCAN\">USCAN<\/option><option value=\"Asian Pacific\">Asian Pacific<\/option><option value=\"Oceania\">Oceania<\/option><\/select><\/span>\n    <div data-id=\"group-europa\" data-orig_data_id=\"group-europa\" data-clear_on_hide class=\"\" data-class=\"wpcf7cf_group\">\n    <span class=\"wpcf7-form-control-wrap\" data-name=\"country1\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required select_nazioni\" id=\"country1\" aria-required=\"true\" aria-invalid=\"false\" name=\"country1\"><option value=\"\">Choose Nation*<\/option><option value=\"Albania\">Albania<\/option><option value=\"Andorra\">Andorra<\/option><option value=\"Armenia\">Armenia<\/option><option value=\"Austria\">Austria<\/option><option value=\"Azerbaijan\">Azerbaijan<\/option><option value=\"Belarus\">Belarus<\/option><option value=\"Belgium\">Belgium<\/option><option value=\"Bosnia and Herzegovina\">Bosnia and Herzegovina<\/option><option value=\"Bulgaria\">Bulgaria<\/option><option value=\"Cyprus\">Cyprus<\/option><option value=\"Croatia\">Croatia<\/option><option value=\"Denmark\">Denmark<\/option><option value=\"Estonia\">Estonia<\/option><option value=\"Finland\">Finland<\/option><option value=\"France\">France<\/option><option value=\"Georgia\">Georgia<\/option><option value=\"Germany\">Germany<\/option><option value=\"Greece\">Greece<\/option><option value=\"Iceland\">Iceland<\/option><option value=\"Ireland\">Ireland<\/option><option value=\"Italy\">Italy<\/option><option value=\"Latvia\">Latvia<\/option><option value=\"Liechtenstein\">Liechtenstein<\/option><option value=\"Lithuania\">Lithuania<\/option><option value=\"Luxembourg\">Luxembourg<\/option><option value=\"Macedonia\">Macedonia<\/option><option value=\"Malta\">Malta<\/option><option value=\"Moldova\">Moldova<\/option><option value=\"Monaco\">Monaco<\/option><option value=\"Montenegro\">Montenegro<\/option><option value=\"Norway\">Norway<\/option><option value=\"Netherlands\">Netherlands<\/option><option value=\"Poland\">Poland<\/option><option value=\"Portugal\">Portugal<\/option><option value=\"United Kingdom\">United Kingdom<\/option><option value=\"Czech Republic\">Czech Republic<\/option><option value=\"Romania\">Romania<\/option><option value=\"Russian Federation\">Russian Federation<\/option><option value=\"San Marino\">San Marino<\/option><option value=\"Serbia\">Serbia<\/option><option value=\"Slovakia\">Slovakia<\/option><option value=\"Slovenia\">Slovenia<\/option><option value=\"Spain\">Spain<\/option><option value=\"Sweden\">Sweden<\/option><option value=\"Switzerland\">Switzerland<\/option><option value=\"Turkey\">Turkey<\/option><option value=\"Ukraine\">Ukraine<\/option><option value=\"Hungary\">Hungary<\/option><\/select><\/span>\n    <\/div>\n    <div data-id=\"group-medio_oriente\" data-orig_data_id=\"group-medio_oriente\" data-clear_on_hide class=\"\" data-class=\"wpcf7cf_group\">\n    <span class=\"wpcf7-form-control-wrap\" data-name=\"country2\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required select_nazioni\" id=\"country2\" aria-required=\"true\" aria-invalid=\"false\" name=\"country2\"><option value=\"\">Choose Nation*<\/option><option value=\"Saudi Arabia\">Saudi Arabia<\/option><option value=\"Bahrain\">Bahrain<\/option><option value=\"Cyprus\">Cyprus<\/option><option value=\"UAE\">UAE<\/option><option value=\"Jordan\">Jordan<\/option><option value=\"Iran\">Iran<\/option><option value=\"Iraq\">Iraq<\/option><option value=\"Israel\">Israel<\/option><option value=\"Kuwait\">Kuwait<\/option><option value=\"Lebanon\">Lebanon<\/option><option value=\"Oman\">Oman<\/option><option value=\"Qatar\">Qatar<\/option><option value=\"Syria\">Syria<\/option><option value=\"Turkey\">Turkey<\/option><option value=\"Yemen\">Yemen<\/option><\/select><\/span>\n    <\/div>\n    <div data-id=\"group-am\" data-orig_data_id=\"group-am\" data-clear_on_hide class=\"\" data-class=\"wpcf7cf_group\">\n    <span class=\"wpcf7-form-control-wrap\" data-name=\"country3\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required select_nazioni\" id=\"country3\" aria-required=\"true\" aria-invalid=\"false\" name=\"country3\"><option value=\"\">Choose Nation*<\/option><option value=\"Argentina\">Argentina<\/option><option value=\"Bolivia\">Bolivia<\/option><option value=\"Brazil\">Brazil<\/option><option value=\"Chile\">Chile<\/option><option value=\"Colombia\">Colombia<\/option><option value=\"Costa Rica\">Costa 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value=\"Vanuatu\">Vanuatu<\/option><option value=\"Vietnam\">Vietnam<\/option><\/select><\/span>\n    <\/div>\n    <div data-id=\"group-oc\" data-orig_data_id=\"group-oc\" data-clear_on_hide class=\"\" data-class=\"wpcf7cf_group\">\n    <span class=\"wpcf7-form-control-wrap\" data-name=\"country6\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required select_nazioni\" id=\"country6\" aria-required=\"true\" aria-invalid=\"false\" name=\"country6\"><option value=\"\">Choose Nation*<\/option><option value=\"Australia\">Australia<\/option><option value=\"New Zealand\">New Zealand<\/option><\/select><\/span>\n    <\/div>\n    <input type=\"hidden\" name=\"country\" value=\"\" size=\"40\" class=\"wpcf7-form-control wpcf7-text country\" id=\"country\" aria-invalid=\"false\">\n    <span class=\"wpcf7-form-control-wrap\" data-name=\"phone\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-validates-as-required wpcf7-text 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so that my personal data can be processed in compliance with the law.<\/span><\/label><\/span><\/span><\/span><\/p>\n         <input class=\"wpcf7-form-control wpcf7-submit has-spinner invio\" id=\"submit\" type=\"submit\" value=\"Submit\" \/>\n      <p class=\"check\" style=\"font-size:10px;\">\n      This site is protected by reCAPTCHA and the Google <a rel=\"nofollow\" href=\"https:\/\/policies.google.com\/privacy\" target=\"_blank\">Privacy Policy<\/a> and <a rel=\"nofollow\" href=\"https:\/\/policies.google.com\/terms\" target=\"_blank\">Terms of Service<\/a> apply.\n      <\/p>\n    <\/div>\n    <div style=\"float:none;clear:left;\"><\/div>\n  <\/div>\n<\/div><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Echolight is pleased to announce that a new process to improve the company organization has been successfully completed, this time aimed at internationalization &nbsp; In the first weeks of 2022, the international body DQS Medizinprodukte GmbH based in Frankfurt am Main (Germany) issued the MDSAP (Medical Device Single Audit Program) certificate to Echolight Spa. It [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":13837,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[32],"tags":[1103,1105,1104,1102],"class_list":["post-13848","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-certificazione-di-qualita","tag-fda","tag-food-and-drug-administration","tag-mdsap"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New quality standard - Echolight<\/title>\n<meta name=\"description\" content=\"Echolight is pleased to announce that a new process to improve the company organization has been successfully completed.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.echolightmedical.com\/en\/new-quality-standard\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New quality standard - 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