{"id":1555,"date":"2026-09-14T21:30:59","date_gmt":"2026-09-14T19:30:59","guid":{"rendered":"https:\/\/helenaolbertova.com\/?page_id=1555"},"modified":"2026-09-14T21:31:00","modified_gmt":"2026-09-14T19:31:00","slug":"about","status":"publish","type":"page","link":"https:\/\/helenaolbertova.com\/cs\/about\/","title":{"rendered":"O mn\u011b"},"content":{"rendered":"
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O mn\u011b<\/p>\n\n\n\n

O mn\u011b<\/h1>\n\n\n\n
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\"Helena<\/figure>\n<\/div>\n\n\n\n
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I am not a theorist. I am a regulatory practitioner. With a Ph.D. in Experimental Oncology and 6+ years of frontline IVDR experience, I specialise in preparing technical files and defending them through Notified Body review rounds to secure final certification.<\/p>\n\n\n\n

Before moving into regulatory work I spent years in cancer biology research at a university hospital and a research institute, planning, running and presenting my own studies. That is why clinical literature and the statistics behind it are familiar ground rather than something I outsource.<\/p>\n\n\n\n

Konzulta\u010dn\u00ed slu\u017eby poskytuji jako samostatn\u00e1 specialistka.<\/strong> Kdy\u017e se mnou spolupracujete, jedn\u00e1te p\u0159\u00edmo se mnou. Ka\u017ed\u00e1 strategie, ka\u017ed\u00fd dokument, ka\u017ed\u00e1 odpov\u011b\u010f ozn\u00e1men\u00e9mu subjektu nese moji osobn\u00ed zku\u0161enost a odpov\u011bdnost. U v\u011bt\u0161\u00edch projekt\u016f mohu p\u0159izvat pe\u010dliv\u011b vybran\u00e9 nez\u00e1visl\u00e9 odborn\u00edky, pokud je skute\u010dn\u011b pot\u0159eba dal\u0161\u00ed kapacita, ale v\u017edy o tom p\u0159edem otev\u0159en\u011b diskutuji. Spolupracuji tak\u00e9 s ov\u011b\u0159en\u00fdmi specialisty v oblastech mimo m\u016fj hlavn\u00ed obor, jako jsou regula\u010dn\u00ed postupy pro software, kompletn\u00ed nastaven\u00ed QMS od nuly nebo budov\u00e1n\u00ed samostatn\u00fdch syst\u00e9m\u016f \u0159\u00edzen\u00ed rizik.<\/p>\n\n\n\n

I combine scientific rigour with smart automation to handle the heavy lifting of regulatory documentation, because most of the weight in a technical file is repetition rather than thinking. Whether you need a gap analysis, a clinical performance report, or straight answers to complex questions, I deliver results rather than reports, so your business moves forward.<\/p>\n\n\n\n

In 2026 I launched Regulatory Path<\/a><\/strong>, an online educational platform. It is the same practice in a different form: I solve IVDR problems hands-on for manufacturers, and when the same problem keeps coming back, I turn it into a course or a template so anyone can solve it themselves. Some clients start with a course and then book a consultation. Others use the courses to train their teams while I handle the certification work.<\/p>\n\n\n\n

I work primarily remotely via Teams, email, and shared cloud platforms. For the right project, I am happy to travel, ideally for a focused week at the start to build the foundations together, then continue remotely with periodic visits as needed. I am not looking to be constantly travelling, but a meaningful on-site presence at key moments is something I genuinely value. I am based in South Moravia, well placed for clients in and around Brno, Bratislava, and Vienna, and reachable across Europe.<\/p>\n\n\n\n

I communicate directly. I do not sugar-coat reality. What I will always give you is honesty about the effort IVDR requires, and the expertise to make that effort count.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Dosavadn\u00ed v\u00fdsledky<\/p>\n\n\n\n

Osv\u011bd\u010den\u00e9 v\u00fdsledky v oblasti dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f IVDR<\/h2>\n\n\n\n
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65+<\/p>\n\n\n\n

produkt\u016f certifikovan\u00fdch podle IVDR.<\/strong> through the full IVDR process, across all device classes A through D.<\/p>\n<\/div>\n<\/div>\n\n\n\n

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400+<\/p>\n\n\n\n

Star\u0161\u00edch prost\u0159edk\u016f (legacy devices)<\/strong> bylo spravov\u00e1no tak, aby byla zaji\u0161t\u011bna nep\u0159etr\u017eit\u00e1 p\u0159\u00edtomnost na trhu EU v souladu s nov\u00fdmi po\u017eadavky IVDR.<\/p>\n<\/div>\n<\/div>\n\n\n\n

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6+<\/p>\n\n\n\n

Let zku\u0161enost\u00ed v oblasti IVDR v p\u0159edn\u00ed linii<\/strong> v\u010detn\u011b p\u0159ipravenosti na audit, interakc\u00ed s ozn\u00e1men\u00fdmi subjekty a spr\u00e1vy zji\u0161t\u011bn\u00ed a zp\u011btn\u00e9 vazby.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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What That Experience Covers<\/h3>\n\n\n\n