{"id":3931,"date":"2025-06-02T15:02:41","date_gmt":"2025-06-02T13:02:41","guid":{"rendered":"https:\/\/mediconomics.com\/cro-for-pmcf-monitoring-under-everyday-conditions\/"},"modified":"2025-06-24T11:26:51","modified_gmt":"2025-06-24T09:26:51","slug":"cro-for-pmcf-monitoring-under-everyday-conditions","status":"publish","type":"page","link":"https:\/\/mediconomics.com\/en\/cro-for-pmcf-monitoring-under-everyday-conditions\/","title":{"rendered":"CRO for PMCF &#8211; monitoring under everyday conditions"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3931\" class=\"elementor elementor-3931 elementor-3782\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-235ad45 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"235ad45\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-9d2b137\" data-id=\"9d2b137\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-32cbcac elementor-widget elementor-widget-image\" data-id=\"32cbcac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"99\" height=\"99\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/03\/Icon_CRO_RGB_blau_2025.png\" class=\"attachment-full size-full wp-image-2026\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-df381a1\" data-id=\"df381a1\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6834490 elementor-widget elementor-widget-heading\" data-id=\"6834490\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">CRO for PMCF - Post Market Clinical Follow-up<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-478f2df elementor-widget elementor-widget-button\" data-id=\"478f2df\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#contact\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cdc931d wellen subsite elementor-widget elementor-widget-html\" data-id=\"cdc931d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"uuid-4b071659-7ca4-4560-8197-62f6aba045f6\" data-name=\"Ebene 2\" viewbox=\"0 0 841.89 570.97\">\n  <defs>\n    <style>\n .uuid-6bf3c995-831e-45fa-a548-05e06c0bcdf1 {\n fill: none;\n stroke: url(#uuid-8d285012-e631-4f90-ab8a-74a7ed5687ac);\n stroke-miterlimit: 10;\n stroke-width: 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 <\/g>\n<\/svg>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3fc2be5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3fc2be5\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ea5389a no-box-shadow-mobile\" data-id=\"ea5389a\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-00a3b1a elementor-widget elementor-widget-heading\" data-id=\"00a3b1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Your partner for clinical follow-up of medical devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-623547d elementor-widget elementor-widget-text-editor\" data-id=\"623547d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Continuous <u>post-market<\/u> <u>clinical<\/u> <u>follow-up<\/u>(PMCF) is known to be essential to ensure the safety and effectiveness of a product after market launch. PMCF studies are an integral part of Post-Market Surveillance (PMS) for medical devices and are even a mandatory part of quality management. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5370aea elementor-widget elementor-widget-text-editor\" data-id=\"5370aea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>It is not always possible to rule out all risks during the approval process, which is why post-market surveillance is also important for your product. Even if these studies initially sound very time-consuming and like a lot of work, thanks to our help, conducting such a study will be the easiest thing in the world for you. We support you in the proactive collection and evaluation of clinical data after your product has been placed on the market and take as much work as possible off your hands in all areas &#8211; from planning to evaluation &#8211; so that you can concentrate on other things.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a8a1661 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a8a1661\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-eb49e70 no-box-shadow-mobile\" data-id=\"eb49e70\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-f26ca56 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f26ca56\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-4849be8\" data-id=\"4849be8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7c2e25b elementor-widget elementor-widget-heading\" data-id=\"7c2e25b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">When are PMCF studies necessary and how are they designed?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-118f4ea elementor-widget elementor-widget-text-editor\" data-id=\"118f4ea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Post-market clinical follow-up studies are necessary and mandatory as soon as a regular market observation cannot provide sufficient clinical data to carry out a mandatory update of the safety data.<\/p><p>The data obtained in these studies represent a subset of the total PMS data and thus supplement the data collected in other studies. PMCF studies are particularly important for novel medical devices or those that are clearly associated with an increased risk. <\/p><p> <\/p><p>First of all, a PMCF plan must be drawn up for all PMCF studies, which defines exactly how the follow-up is to be carried out. In addition to the evaluation and observation of the company&#8217;s own product, similar products are also used to evaluate the data. The PMCF plan is a component of the Post Market Surveillance Plan (PMS plan).  <\/p><p> <\/p><p><em>Together with our sister company Medicoforum GmbH, we are experts in the field of conducting PMCF studies.<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6edff40 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6edff40\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-789a30a\" data-id=\"789a30a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ed60dbf elementor-widget elementor-widget-heading\" data-id=\"ed60dbf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Our services in the area of PMCF<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a814f5 elementor-widget elementor-widget-text-editor\" data-id=\"4a814f5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>As a CRO with over 25 years of experience, we have regularly supported clients who wanted to carry out PMCF studies as efficiently and conscientiously as possible. Over the years, we have been able to develop concepts that enable us to offer individual and customized solutions for each client. With us you get:  <\/p><ul><li>Development of an individual PMCF plan under real application conditions<\/li><li>Advice and support for the successful implementation of the developed strategies<\/li><li>Creation of PMCF processes, plans and reports<\/li><li>Support with case number planning and evaluation of the generated data<\/li><li>Planning, implementation and supervision of your PMCF study (e.g. long-term observations of patients or studies on known risks from the literature)<\/li><li>Observational studies (under routine conditions)<\/li><li>Retrospective evaluation of existing user data<\/li><li>Monitoring the scientific literature<\/li><li>Evaluation of other PMS activities<\/li><li>Regulatory support from start to finish<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-46ecbff elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"46ecbff\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-098f1d6\" data-id=\"098f1d6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e43a25b elementor-widget elementor-widget-heading\" data-id=\"e43a25b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">MDR requirements for the data collected<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d183220 elementor-widget elementor-widget-text-editor\" data-id=\"d183220\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The European Medical Device Regulation requires proactive, continuous, objective and thorough documentation and performance of clinical evaluations (Article 61; Clinical evaluation, Annex XIV; MDR). Furthermore, the manufacturer of a medical device is obliged to collect and regularly update the documentation and clinical data generated on the basis of the clinical follow-up plan over the entire life cycle of the device. Particular attention must be paid to this:  <\/p><ul><li><strong>Data collection: <\/strong>Data on quality, safety, usability, justifiability of the risk-benefit ratio and performance of the product are collected. The data collected is used to identify necessary corrective measures and implement appropriate interventions. <\/li><li><strong>Determining the scope according to the type of device: <\/strong>The scope and thoroughness of the assessment to be carried out will vary depending on the classification, intended purpose, type and risks of the device. For some devices, further clinical surveillance may not be considered necessary if sufficiently justified and documented. <\/li><li><strong>Reporting obligations:<\/strong> PMCF activities make it possible to identify unknown side effects and contraindications as early as possible. Furthermore, systematic errors or applications outside of the approval can be identified and thus necessitate a re-evaluation of the intended use. Any safety corrective actions and incidents must be reported to the authorities immediately and investigated.  <\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-31ac461 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"31ac461\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-924d119\" data-id=\"924d119\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1c01bc3 elementor-widget elementor-widget-heading\" data-id=\"1c01bc3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Place your trust in our expertise<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1b18e75 elementor-widget elementor-widget-text-editor\" data-id=\"1b18e75\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Benefit from our team of experts and their many years of experience in conducting PMCF studies. With us, you get the complete package and we support you in all duties and activities of clinical follow-up &#8211; from the preparation of the plan to communication with the authorities in the event of necessary notifications &#8211; with us, your project will always be implemented in an uncomplicated and timely manner. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6d38b777 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6d38b777\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-48169096 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value=\"27\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/3931\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-27\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Send\" aria-live=\"assertive\" value=\"wpforms-submit\">Send<\/button><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/mediconomics.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container --><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-50245fc columns-mobile-and-tablet elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"50245fc\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-b76962d\" data-id=\"b76962d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d8b5e67 image-br elementor-widget elementor-widget-image\" data-id=\"d8b5e67\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"833\" height=\"1024\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-833x1024.jpg\" class=\"attachment-large size-large wp-image-1982\" alt=\"Uwe_Albrecht\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-833x1024.jpg 833w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-244x300.jpg 244w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-768x944.jpg 768w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-1250x1536.jpg 1250w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025.jpg 1512w\" sizes=\"(max-width: 833px) 100vw, 833px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-219b2e9 elementor-widget elementor-widget-text-editor\" data-id=\"219b2e9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Dr. (MD) Uwe Albrecht,<br>FIBMS, FFPM (Dis.), FICR, CSci<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20fc7bb elementor-widget elementor-widget-text-editor\" data-id=\"20fc7bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Managing Director<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-f490ede\" data-id=\"f490ede\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-991e429 image-br elementor-widget elementor-widget-image\" data-id=\"991e429\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"605\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-1024x605.jpg\" class=\"attachment-large size-large wp-image-1983\" alt=\"Hauptsitz_Mediconomics\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-1024x605.jpg 1024w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-300x177.jpg 300w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-768x454.jpg 768w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-1536x907.jpg 1536w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d758337 elementor-widget elementor-widget-text-editor\" data-id=\"d758337\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Head office<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2541fad elementor-widget elementor-widget-text-editor\" data-id=\"2541fad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Hanover<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-bc5f915 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"bc5f915\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e8e7f7d\" data-id=\"e8e7f7d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3ed630d elementor-widget elementor-widget-heading\" data-id=\"3ed630d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><b>FAQ<\/b> - FREQUENTLY ASKED QUESTIONS<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad92ceb elementor-widget elementor-widget-html\" data-id=\"ad92ceb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\n  Can Mediconomics also support me with multinational PMCF studies?\n    <\/div>\n    <div class=\"dropdown-content\">\n  Yes! We have experience in conducting multinational studies in a wide range of specialist areas and have an international network at our disposal. We know the country-specific regulatory requirements and can coordinate your study efficiently across national borders.  \n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0bd21a9 elementor-widget elementor-widget-html\" data-id=\"0bd21a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\n  What are the special features of conducting PMCF studies?\n    <\/div>\n    <div class=\"dropdown-content\">\n  Conducting PMCF studies requires particularly precise planning, rigorous execution and ongoing monitoring to ensure that your medical device remains safe and effective after market approval. Challenges can arise at any point, such as \n        <ul class=\"medico-list-checked\">\n            <li>\n  Regulatory requirements and compliance in data collection and reporting\n            <\/li>\n            <li>\n  Matching the objectives and design of the study to the product\n            <\/li>\n            <li>\n  Selection of the appropriate study population\n            <\/li>\n            <li>\n  Data collection over a long-term period\n            <\/li>\n            <li>\n  Integration of real data into the overall assessment of the product\n            <\/li>\n            <li>\n  Flexible design and customization of the study  \n            <\/li>\n        <\/ul>\n\n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-261a85f elementor-widget elementor-widget-html\" data-id=\"261a85f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\n  What are the advantages of working with Mediconomics for PMCF studies?\n    <\/div>\n    <div class=\"dropdown-content\">\n  We offer you:\n        <ul class=\"medico-list-checked\">\n            <li>\n  In-depth expertise in the field of medical devices and various medical specialties\n            <\/li>\n            <li>\n  Creation of individual plans for the realization of your project\n            <\/li>\n            <li>\n  Optimized processes for conducting PMCF studies\n            <\/li>\n            <li>\n  Access to a network of experts and test centers, as well as close cooperation with them\n            <\/li>\n            <li>\n  Most efficient study processes by our experts in all areas of clinical research\n            <\/li>\n        <\/ul>\n\n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>CRO for PMCF &#8211; Post Market Clinical Follow-up Contact us Your partner for clinical follow-up of medical devices Continuous post-market clinical follow-up(PMCF) is known to be essential to ensure the safety and effectiveness of a product after market launch. PMCF studies are an integral part of Post-Market Surveillance (PMS) for medical devices and are even [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","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":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","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":"default","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-3931","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/3931","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/comments?post=3931"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/3931\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=3931"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}