{"id":76,"date":"2022-07-25T10:03:19","date_gmt":"2022-07-25T08:03:19","guid":{"rendered":"https:\/\/www.biotopmedical.nl\/?page_id=76"},"modified":"2026-01-20T09:58:22","modified_gmt":"2026-01-20T08:58:22","slug":"home","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/","title":{"rendered":"Home"},"content":{"rendered":"

[vc_row full_width=”stretch_row” content_placement=”bottom” bg_color=”bg_purple” bg_fade=”fade_white” css=”.vc_custom_1670580737571{background-image: url(https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/home_banner.jpg?id=505) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column width=”7\/12″]\r\n

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Wij zijn BioTop Medical<\/h1>\r\n <\/div>\r\n
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Een op maat gemaakte strategie voor de naleving van de regelgeving<\/h2>\r\n <\/div>[vc_row_inner][vc_column_inner width=”5\/12″]\r\n
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Kwaliteitsmanagement Systeem<\/h3>\r\n <\/div>\r\n
\r\n Implementatie QMS<\/svg><\/a>\r\n <\/div>\r\n
\r\n Audits<\/svg><\/a>\r\n <\/div>[\/vc_column_inner][vc_column_inner width=”5\/12″]\r\n
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Technische documentatie<\/h3>\r\n <\/div>\r\n
\r\n Risicobeheer<\/svg><\/a>\r\n <\/div>\r\n
\r\n Klinische evaluatie<\/svg><\/a>\r\n <\/div>\r\n
\r\n Systematisch literatuuronderzoek<\/svg><\/a>\r\n <\/div>\r\n
\r\n Biologisch evaluatierapport<\/svg><\/a>\r\n <\/div>\r\n
\r\n Overig<\/svg><\/a>\r\n <\/div>[\/vc_column_inner][vc_column_inner width=”1\/12″][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column css_animation=”fadeInUp” width=”5\/12″]\r\n \r\n
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Laat ons helpen met uw documenten<\/h2>\r\n <\/div>\r\n
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Wij hebben veel ervaring met het schrijven en beoordelen van documenten zoals het literatuuronderzoek rapport, het klinische evaluatie- of prestatie evaluatierapport, het biologische evaluatierapport, de technische documenten betreft bruikbaarheid, het risicomanagement dossier, de Post-Market Surveillance Plan en het periodieke veiligheidsupdate rapport. Wij zijn er om u te helpen dus laat ons weten wat uw vragen zijn.<\/p>\n\r\n <\/div>\r\n \r\n

\r\n Meer informatie over onze diensten<\/span>\r\n <\/div>\r\n <\/div>\r\n \r\n <\/a>[\/vc_column][\/vc_row][vc_row full_width=”stretch_row”][vc_column css_animation=”fadeInUp”]\r\n
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Toegang tot de markt voor bedrijven in medische hulpmiddelen<\/h2>\r\n <\/div>[vc_row_inner equal_height=”yes”][vc_column_inner width=”1\/3″]\r\n \r\n \r\n \r\n \r\n
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Starters<\/h2>\r\n <\/div>\r\n
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U heeft een jong en dynamisch bedrijf en met trots ontwikkelt u een uniek hulpmiddel.<\/p>\n\r\n <\/div>\r\n \r\n

\r\n Meer informatie<\/span>\r\n <\/div>\r\n <\/div>\r\n \r\n <\/a>[\/vc_column_inner][vc_column_inner width=”1\/3″]\r\n \r\n \r\n \r\n \r\n
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Middelgrote ondernemingen<\/h2>\r\n <\/div>\r\n
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Uw bedrijf is al een aantal jaren succesvol actief.<\/p>\n\r\n <\/div>\r\n \r\n

\r\n Meer informatie<\/span>\r\n <\/div>\r\n <\/div>\r\n \r\n <\/a>[\/vc_column_inner][vc_column_inner width=”1\/3″]\r\n \r\n \r\n \r\n \r\n
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Gevestigde multinationals<\/h2>\r\n <\/div>\r\n
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Uw bedrijf bestaat al geruime tijd, is goed bekend en is succesvol op het gebied van medische hulpmiddelen.<\/p>\n\r\n <\/div>\r\n \r\n

\r\n Meer informatie<\/span>\r\n <\/div>\r\n <\/div>\r\n \r\n <\/a>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” bg_color=”bg_lightpurple”][vc_column css_animation=”fadeInUp”]\r\n
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Over BioTop Medical<\/h2>\r\n <\/div>[vc_row_inner][vc_column_inner width=”5\/12″]\r\n
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BioTop Medical levert sinds 1997 diensten op het gebied van kwaliteitsmanagementsystemen en regelgeving aan bedrijven die werkzaam zijn in de medische hulpmiddelen sector. Hiermee ondersteunen we bedrijven wanneer zij hun producten op de Europese en Noord-Amerikaanse markt brengen.<\/p>\n

Ons doel is om samen met onze klanten specifieke strategie\u00ebn te ontwikkelen om aan de regelgeving te voldoen. Dit doen we op een zo flexibel, effici\u00ebnt en effectief mogelijke wijze.<\/p>\n

Wij ondersteunen onze klanten bij de ontwikkeling en implementatie van op maat gemaakte processen die nodig zijn om hun producten op de markt te brengen. Wij bieden hierbij praktijkgerichte ondersteuning op het gebied van regelgeving en kwaliteitsmanagementsystemen.<\/p>\n

BioTop Medical bouwt langetermijnrelaties met klanten op wat garantie biedt voor goede product- en proceskennis.<\/p>\n\r\n <\/div>\r\n

\r\n Meer over ons<\/a>\r\n <\/div>[\/vc_column_inner][vc_column_inner width=”1\/12″][\/vc_column_inner][vc_column_inner width=”1\/2″]\r\n
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Wij zijn gevestigd in het monumentale Poortgebouw in Leiden.<\/p>\n\r\n <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

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