{"id":1311,"date":"2023-06-29T07:50:12","date_gmt":"2023-06-29T07:50:12","guid":{"rendered":"https:\/\/demosites.io\/online-course-2-gb\/?page_id=4"},"modified":"2026-04-29T15:56:00","modified_gmt":"2026-04-29T15:56:00","slug":"ec3e5-homepage","status":"publish","type":"page","link":"https:\/\/www.grootsmdexpert.nl\/FastCE\/","title":{"rendered":"QA\/RA Consultancy MedTech- Your MDR\/ IVDR\/ ISO 13485\/ ISO 27001 expert"},"content":{"rendered":"\n
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Unlock your full market potential with our pragmatic CE, ISO 13485 and ISO 27001 support<\/strong><\/h1>\n\n\n\n

Apply proven, pragmatic strategies to build a compliant Quality Management System, audit-ready documentation, and accelerate your path to market. Delivered with efficiency and supported by deep quality and regulatory expertise.<\/p>\n\n\n\n

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Unlock market access<\/strong><\/strong><\/h3>\n\n\n\n

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Get certified faster with end-to-end ISO 27001, ISO 13485 and CE support, from initial application to ongoing compliance<\/p>\n<\/div>\n\n\n\n

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Smooth market access<\/strong><\/strong><\/h3>\n\n\n\n

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Reduce delays and simplify approvals with our proven process and hands-on support.<\/p>\n<\/div>\n\n\n\n

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Building Relationships<\/strong><\/h3>\n\n\n\n

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Trust is essential for every PRRC relationship, it\u2019s what enables us to protect your organisation and ensure full regulatory compliance.<\/p>\n<\/div>\n<\/div><\/section>\n<\/div>\n<\/div><\/section>\n\n\n\n

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Our Story<\/h2>\n\n\n\n

We started with one mission: ensure that safe and effective medical devices and in-vitro diagnostic devices will reach the market to make an impact on the world. Our excellence services are based on real-world experience, avoiding delays in market access.<\/p>\n\n\n\n

Supporting (start-up) medical device manufacturers, distributors, importers and authorised representatives<\/p>\n\n\n\n

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Our Services<\/strong><\/h2>\n<\/div>\n<\/div>\n\n\n\n
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Regulatory Compliance Services<\/strong> <\/h4>\n\n\n\n

Get better results with less effort by using systems that save time and boost consistency. <\/p>\n\n\n\n

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Quality Management System<\/strong><\/h4>\n\n\n\n

Development, implementation, and optimization of your Quality Management System.<\/p>\n\n\n\n

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Training Programs Professionals<\/strong> <\/h4>\n\n\n\n

We offer a diverse range of hands-on training courses, e.g. MDR\/ ISO 13485\/ ISO 14971.<\/p>\n\n\n\n

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Auditing Services f0r Experts<\/strong> <\/h4>\n\n\n\n

Audit services for different types of audits, e.g. Internal, Supplier and Notified Body.<\/p>\n\n\n\n

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Strategic Advice for MDs & IVDs<\/strong><\/h4>\n\n\n\n

Strategic advice to navigate the complex regulatory landscape for market access.<\/p>\n\n\n\n

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Ready to take the next step? Let\u2019s call.<\/a><\/div>\n\n\n\n
Interested in our services? Get in touch today.<\/a><\/div>\n<\/div>\n\n\n\n
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Driven by Results<\/h2>\n\n\n\n

Our service is your smootest way to CE<\/p>\n\n\n\n

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15+<\/h3>\n\n\n\n

YEARs of experience<\/p>\n<\/div>\n\n\n\n

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75+<\/h3>\n\n\n\n

happy customers<\/p>\n<\/div>\n\n\n\n

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10+<\/h3>\n\n\n\n

Experience with different notified bodies<\/p>\n<\/div>\n\n\n\n

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150+<\/h3>\n\n\n\n

Professionals trained<\/p>\n<\/div>\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n

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What Our Customers Are Saying<\/strong><\/h2>\n<\/div>\n<\/div><\/div>\n\n\n\n
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Ward van Buul, Jointsphere B.V.<\/strong><\/p>\n\n\n\n

Lizette demonstrated exceptional dedication, guiding us smoothly toward a successful Stage 1 audit. Her professionalism, energy, and clear expertise made the entire process a pleasure. With the first steps toward Stage 2 already underway, I\u2019m fully confident that we\u2019ll achieve another great result.<\/p>\n\n\n\n

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Tom Doodkorte, Enraf-Nonius BV<\/strong><\/p>\n\n\n\n

\u201cTaken through the landscape (and all obligations) of the MDR in a very structured way. It was a pragmatic and hands-on training. Thank you so much\u201d<\/p>\n\n\n\n

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REGINA SHih, COOPERSURGICAL INC<\/strong><\/p>\n\n\n\n

I would recommend Lizette to any medical device company who needs support for MDR compliance. She has always been on top of all tasks and was able to identify many areas for improvement by her incredible audit skills and insight for the quality management system. Her knowledge in the EU MDR regulation and compliance requirements is solid.<\/p>\n\n\n\n

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BILIHOME B.V.<\/strong><\/p>\n\n\n\n

Just recently Lizette has guided us through the 510(k) approach for our solution. Not only confirming our regulatory strategy, she even gave us concrete step-by-step approach towards an FDA approval. This helps us to plan time and money. Bilihome can recommend Lizette de Groot for a first and thorough assessment of a regulatory pathway to the US.<\/p>\n\n\n\n

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Let us help you to create your success story<\/a><\/div>\n\n\n\n
Ready for the same results? Call us today<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n
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Obtain your CE marking<\/strong>, ISO 13485 certification and ISO 27001 certification<\/strong> with confidence.<\/strong><\/h2>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n
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Call<\/a><\/div>\n\n\n\n
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Services<\/a><\/div>\n\n\n\n
Expertise<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Our Services Our service is your smootest way to CE Obtain your CE marking, ISO 13485 certification and ISO 27001 certification with confidence.<\/p>\n","protected":false},"author":1,"featured_media":1573,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/template-pagebuilder-full-width.php","meta":{"neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"","neve_meta_content_width":0,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"on","_themeisle_gutenberg_block_has_review":false,"footnotes":""},"class_list":["post-1311","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.grootsmdexpert.nl\/FastCE\/index.php?rest_route=\/wp\/v2\/pages\/1311","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.grootsmdexpert.nl\/FastCE\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.grootsmdexpert.nl\/FastCE\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.grootsmdexpert.nl\/FastCE\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.grootsmdexpert.nl\/FastCE\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1311"}],"version-history":[{"count":52,"href":"https:\/\/www.grootsmdexpert.nl\/FastCE\/index.php?rest_route=\/wp\/v2\/pages\/1311\/revisions"}],"predecessor-version":[{"id":1583,"href":"https:\/\/www.grootsmdexpert.nl\/FastCE\/index.php?rest_route=\/wp\/v2\/pages\/1311\/revisions\/1583"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.grootsmdexpert.nl\/FastCE\/index.php?rest_route=\/wp\/v2\/media\/1573"}],"wp:attachment":[{"href":"https:\/\/www.grootsmdexpert.nl\/FastCE\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1311"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}