{"id":42,"date":"2021-01-10T13:56:02","date_gmt":"2021-01-10T13:56:02","guid":{"rendered":"https:\/\/www.grootsivdexpert.nl\/?page_id=42"},"modified":"2025-06-24T08:57:08","modified_gmt":"2025-06-24T08:57:08","slug":"expertise","status":"publish","type":"page","link":"https:\/\/www.grootsivdexpert.nl\/index.php\/expertise\/","title":{"rendered":"Expertise"},"content":{"rendered":"\n<p><\/p>\n\n\n\n<p><strong>Groots In Vitro Diagnostic Expert<\/strong> is your <strong><em>excellence<\/em> MDR, IVDR and ISO 13485 consultant<\/strong> to ensure quick market access. <\/p>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p>The expertise of <strong><strong>Groots In Vitro Diagnostic Expert<\/strong> <\/strong>is gained through:<\/p>\n\n\n\n<p><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-style-large is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Over 15 years\u2019 experience in the medical device industry<\/p>\n<\/blockquote>\n\n\n\n<p><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-style-large is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Broad experience with Quality Management Systems and Market Access of various (in vitro diagnostic) medical devices:<\/p>\n<\/blockquote>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>At Notified Body <a href=\"https:\/\/www.dare.eu\/notified-body-medical-devices\">Kiwa Dare!<\/a> for CE marking of medical devices conform the Medical Device Regulation (MDR) as certified lead auditor, product reviewer and application reviewer &amp; for ISO certification of Quality Management System conform EN-ISO 13485 as certified lead auditor and application reviewer<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>At various medical device companies in Quality Assurance &amp; Regulatory Affairs functions<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Proven market access in the following regions: Europe, North-America, Asia, Australia, Middle-East, Africa and Latin America&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Setting up Quality Management System conform <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32017R0745\">MDR 2017\/745<\/a>, <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj\" data-type=\"URL\" data-id=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj\">IVDR 2017\/746<\/a>, the latest version of the <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en\">MDCGs<\/a>,  the latest version of the EN-ISO 13485, the latest version of the EN-ISO 27001 and <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=820\">21 CFR 820<\/a><\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Participation NEN Expert Group &#8216;Artificial Intelligence &amp; Medical Devices&#8217;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Acting as trainer for <a href=\"https:\/\/mikrocentrum.nl\/nl\/medical-devices-en-medische-kwaliteitsnormen\/\" data-type=\"URL\" data-id=\"https:\/\/mikrocentrum.nl\/nl\/medical-devices-en-medische-kwaliteitsnormen\/\">Mikrocentrum<\/a> for various courses<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Different product types and classifications\n<ul class=\"wp-block-list\">\n<li>Active and Non-Active (sterile and non-sterile) medical devices<\/li>\n\n\n\n<li>Invasive and Non-invasive medical devices<\/li>\n\n\n\n<li>(Active) Implantable Medical Devices <\/li>\n\n\n\n<li>Class IIb, Class IIa, Class Is, Class Ir &amp; Im Medical devices<\/li>\n\n\n\n<li>Class A, B and C (In Vitro Diagnostic Medical Devices)<\/li>\n\n\n\n<li>Class A, B and C software medical devices<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>Experience with various eQMS systems, e.g. but not limited to: <a href=\"https:\/\/www.greenlight.guru\/\">Greenlight Guru<\/a>, <a href=\"https:\/\/www.scilife.io\/\">Scilife<\/a>, <a href=\"https:\/\/www.bizzmine.com\/en\/solutions\/digital-qms?utm_feeditemid=&amp;utm_device=c&amp;utm_term=bizzmine&amp;utm_source=google&amp;utm_medium=ppc&amp;utm_campaign=%5BNL+ENG%5D+High+Intent&amp;hsa_cam=20254183390&amp;hsa_grp=147240277102&amp;hsa_mt=b&amp;hsa_src=g&amp;hsa_ad=661147541450&amp;hsa_acc=8934993692&amp;hsa_net=adwords&amp;hsa_kw=bizzmine&amp;hsa_tgt=kwd-870947253766&amp;hsa_ver=3&amp;gad_source=1&amp;gclid=CjwKCAjw68K4BhAuEiwAylp3kpb6IeDE4a_lbOdWqJ5i4zFyLcwZzkm_0EZ0WQtfwPhie2mdG9JywRoCnosQAvD_BwE\">Bizzmine,<\/a> <a href=\"https:\/\/www.cognidox.com\/\" data-type=\"link\" data-id=\"https:\/\/www.cognidox.com\/\">Cognidox<\/a> and <a href=\"https:\/\/matrixreq.com\/\">Matrix Requirements<\/a>. The most cost-effective and most efficient system is the <a href=\"https:\/\/www.cognidox.com\/\">Cognidox<\/a> eQMS.<\/p>\n\n\n\n<p>More information about our excellence services? <\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image aligncenter size-large is-resized is-style-rounded\"><img fetchpriority=\"high\" decoding=\"async\" width=\"683\" height=\"1024\" src=\"https:\/\/www.grootsivdexpert.nl\/wp-content\/uploads\/2025\/06\/0Q7A9309-683x1024.jpg\" alt=\"\" class=\"wp-image-564\" style=\"width:201px;height:auto\" srcset=\"https:\/\/www.grootsivdexpert.nl\/wp-content\/uploads\/2025\/06\/0Q7A9309-683x1024.jpg 683w, https:\/\/www.grootsivdexpert.nl\/wp-content\/uploads\/2025\/06\/0Q7A9309-200x300.jpg 200w, https:\/\/www.grootsivdexpert.nl\/wp-content\/uploads\/2025\/06\/0Q7A9309-768x1152.jpg 768w, https:\/\/www.grootsivdexpert.nl\/wp-content\/uploads\/2025\/06\/0Q7A9309-1024x1536.jpg 1024w, https:\/\/www.grootsivdexpert.nl\/wp-content\/uploads\/2025\/06\/0Q7A9309-1365x2048.jpg 1365w, https:\/\/www.grootsivdexpert.nl\/wp-content\/uploads\/2025\/06\/0Q7A9309-scaled.jpg 1707w\" sizes=\"(max-width: 683px) 100vw, 683px\" \/><figcaption class=\"wp-element-caption\"><a rel=\"noreferrer noopener\" href=\"http:\/\/linkedin.com\/in\/lizette-de-groot-bb578219\" target=\"_blank\">Lizette de Groot &#8211; van de Streek<\/a><br>CEO &amp; Senior consultant<\/figcaption><\/figure>\n<\/div>\n<\/div>\n\n\n\n<p class=\"has-vivid-purple-color has-text-color has-link-color wp-elements-0a2118b0fc2a57bb4fb1350a125146ca\"><strong>Contact our senior consultant Lizette<\/strong><\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"tel: +31611205195\">Call<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"Mailto: l.degroot@grootsmdexpert.nl\">Email<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Groots In Vitro Diagnostic Expert is your excellence MDR, IVDR and ISO 13485 consultant to ensure quick market access. The expertise of Groots In Vitro Diagnostic Expert is gained through: Over 15 years\u2019 experience in the medical device industry Broad experience with Quality Management Systems and Market Access of various (in vitro diagnostic) medical devices: [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-42","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.grootsivdexpert.nl\/index.php\/wp-json\/wp\/v2\/pages\/42","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.grootsivdexpert.nl\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.grootsivdexpert.nl\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.grootsivdexpert.nl\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.grootsivdexpert.nl\/index.php\/wp-json\/wp\/v2\/comments?post=42"}],"version-history":[{"count":32,"href":"https:\/\/www.grootsivdexpert.nl\/index.php\/wp-json\/wp\/v2\/pages\/42\/revisions"}],"predecessor-version":[{"id":571,"href":"https:\/\/www.grootsivdexpert.nl\/index.php\/wp-json\/wp\/v2\/pages\/42\/revisions\/571"}],"wp:attachment":[{"href":"https:\/\/www.grootsivdexpert.nl\/index.php\/wp-json\/wp\/v2\/media?parent=42"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}