{"id":2,"date":"2026-02-28T11:24:42","date_gmt":"2026-02-28T11:24:42","guid":{"rendered":"https:\/\/medicinal-product-launch.de\/?page_id=2"},"modified":"2026-04-11T15:37:37","modified_gmt":"2026-04-11T15:37:37","slug":"sample-page","status":"publish","type":"page","link":"https:\/\/medicinal-product-launch.de\/?page_id=2","title":{"rendered":""},"content":{"rendered":"\n
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Achieve your goals with my expertise<\/strong><\/p>\n\n\n\n

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Welcome <\/strong><\/h4>\n\n\n\n

My name is Silvia Wallberg and as a dedicated regulatory affairs managerin and passionate medical writer I provide freelance medical writing services to medical device companies, those manufacturers or Market Authorization holders who want to launch a medical product, CROs, and service providers.<\/p>\n\n\n\n

I also offer my service in writing and\/or proofreading of CTD-Dossiers for medicines.<\/p>\n\n\n\n

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Furthermore, I specialized in supporting medical device companies and manufacturers seeking to launch new products. I support during build up and help enhance existing Quality Management Systems to meet ISO 13485 and ISO 14971 standards for production of Medical Devices.<\/p>\n\n\n\n

My background in biomedical sciences (University of L\u00fcbeck) and an additional Regulatory Affairs Certification for medicinal products, medical devices and medicines (further education at Dr. Nothgi Research GmbH) is the professional foundation I offer.<\/p>\n\n\n\n

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\u201eWenn du keine kalkulierten Risiken eingehst, wird sich auch nichts ver\u00e4ndern!\u201c<\/p>\n<\/blockquote>\n\n\n\n

My strengths are:<\/strong><\/p>\n\n\n\n

– structuring and summarizing complex scientific data in a clear and concise manner with a high attention to detail and quality.<\/p>\n\n\n\n

– professional knowledge about techniques for collection and presentation of data in Literature searches, building CEPs, CERs, PSURs, PMCF-documents, writing CTD-Dossiers Modul 1-5, criteria for monitoring and evaluation of clinical trials.<\/p>\n\n\n\n

– experiece in implementing <\/p>\n\n\n\n

ISO 13485 and ISO 14971 and a Post Market Survellance System into existing Quality Management Systems, <\/p>\n\n\n\n

giving guidance to achieve compliance for audition by the notified body and achieving market authorization, <\/p>\n\n\n\n

help with registration of medical devices and nutritional supplements worldwide<\/p>\n\n\n\n

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This site also offers templates to download for future manufacturers of medical devices or medicinal products to build their Quality Management System according to ISO 13485 and ISO 14791, ready for Post market surveillance and Vigilance.<\/p>\n\n\n\n

As a member of the European Medical Writers Association (EMWA) I regularly participate in trainings regarding regulatory topics and clinical evaluation of medical devices.<\/p>\n\n\n\n

Depending on your demand, I provide all my services in English or German language.<\/p>\n\n\n\n

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Medical Writing Service & QMSyst. Buildup<\/a><\/p>\n\n<\/div>\n\n\n\n

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\n\t\tGestaltet mit WordPress<\/a>\t<\/p>\n<\/div>\n\n\n\n

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  Achieve your goals with my expertise Welcome My name is Silvia Wallberg and as a dedicated regulatory affairs managerin and passionate medical writer I provide freelance medical writing services to medical device companies, those manufacturers or Market Authorization holders who want to launch a medical product, CROs, and service providers. I also offer my […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"class_list":["post-2","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/medicinal-product-launch.de\/index.php?rest_route=\/wp\/v2\/pages\/2","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medicinal-product-launch.de\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/medicinal-product-launch.de\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/medicinal-product-launch.de\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medicinal-product-launch.de\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2"}],"version-history":[{"count":23,"href":"https:\/\/medicinal-product-launch.de\/index.php?rest_route=\/wp\/v2\/pages\/2\/revisions"}],"predecessor-version":[{"id":159,"href":"https:\/\/medicinal-product-launch.de\/index.php?rest_route=\/wp\/v2\/pages\/2\/revisions\/159"}],"wp:attachment":[{"href":"https:\/\/medicinal-product-launch.de\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}