{"id":1656,"date":"2024-07-31T15:07:30","date_gmt":"2024-07-31T13:07:30","guid":{"rendered":"https:\/\/telemon.care\/?p=1656"},"modified":"2026-02-05T15:21:06","modified_gmt":"2026-02-05T14:21:06","slug":"vdaka-medzinarodnemu-certifikatu-mdr-moze-riesenie-telemon-sluzit-este-sirsiemu-spektru-pacientov-lubos-petrik","status":"publish","type":"post","link":"https:\/\/telemon.care\/sk\/vdaka-medzinarodnemu-certifikatu-mdr-moze-riesenie-telemon-sluzit-este-sirsiemu-spektru-pacientov-lubos-petrik\/","title":{"rendered":"V\u010faka medzin\u00e1rodn\u00e9mu certifik\u00e1tu MDR m\u00f4\u017ee rie\u0161enie Telemon sl\u00fa\u017ei\u0165 e\u0161te \u0161ir\u0161iemu spektru pacientov. Lubo\u0161 Petr\u00edk"},"content":{"rendered":"

V m\u00e1ji 2024 z\u00edskalo telemedic\u00ednske rie\u0161enie Telemon prest\u00ed\u017eny MDR certifik\u00e1t. O\u00a0jeho v\u00fdzname sme sa porozpr\u00e1vali s \u013dubo\u0161om Petr\u00edkom, predsedom predstavenstva spolo\u010dnosti Goldmann Systems.<\/p>\n

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Rie\u0161enie Telemon z dielne Goldmann Systems ned\u00e1vno z\u00edskalo MDR certifik\u00e1t. Pre\u010do je t\u00e1to certifik\u00e1cia d\u00f4le\u017eit\u00e1?<\/h3>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n
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Certifik\u00e1t MDR, \u010do je skratka pre Medical Device Regulation, je medzin\u00e1rodn\u00e9 osved\u010denie vyd\u00e1van\u00e9 nez\u00e1vislou certifika\u010dnou autoritou, ktor\u00e1 overuje v\u0161etky kvalitat\u00edvne, bezpe\u010dnostn\u00e9 a u\u017e\u00edvate\u013esk\u00e9 aspekty pou\u017e\u00edvania technol\u00f3gie.<\/p>\n

Povedan\u00e9 \u013eudskou re\u010dou, tento certifik\u00e1t dokazuje s\u00falad rie\u0161enia\u00a0 s najvy\u0161\u0161\u00edmi \u0161tandardmi bezpe\u010dnosti a kvality. Potvrdzuje, \u017ee na\u0161a platforma pren\u00e1\u0161a d\u00e1ta korektne, v\u010das a spr\u00e1vne a \u017ee s\u00fa dostato\u010dne zabezpe\u010den\u00e9 a zdie\u013ean\u00e9 iba s opr\u00e1vnen\u00fdmi entitami. To znamen\u00e1 nielen z\u00e1ruku bezpe\u010dnosti pre pacientov, ale z\u00e1rove\u0148 aj pre medic\u00ednsky person\u00e1l, ktor\u00fd si m\u00f4\u017ee by\u0165 ist\u00fd, \u017ee d\u00e1ta, ktor\u00e9 zbiera, s\u00fa naozaj medic\u00ednsky spr\u00e1vne.<\/p>\n

Telemon, samozrejme, v\u0161etky tieto aspekty sp\u013a\u0148al aj predt\u00fdm. Teraz to v\u0161ak pos\u00fadila aj nez\u00e1visl\u00e1 akreditovan\u00e1 in\u0161tit\u00facia. Z\u00e1rove\u0148 by som r\u00e1d zd\u00f4raznil, \u017ee Telemon je jednou z m\u00e1la glob\u00e1lnych technol\u00f3gi\u00ed v\u00f4bec, ktor\u00e1 je t\u00fdmto sp\u00f4sobom certifikovan\u00e1.<\/p>\n

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\u201eTelemon je jednou z m\u00e1la glob\u00e1lnych technol\u00f3gi\u00ed v\u00f4bec, ktor\u00e1 je t\u00fdmto sp\u00f4sobom certifikovan\u00e1 pre oblas\u0165 SW zdravotn\u00edckej pom\u00f4cky.\u201c<\/em><\/p>\n

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Pre\u010d\u00edtajte si aj:<\/h3>\n<\/div>\n<\/div>\n
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Rie\u0161enie Telemon z\u00edskalo prest\u00ed\u017eny medzin\u00e1rodn\u00fd certifik\u00e1t MDR<\/a><\/h3>\n

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Ak\u00fd pr\u00ednos bude ma\u0165 t\u00e1to certifik\u00e1cia pre pacientov a pou\u017e\u00edvate\u013eov Telemon?<\/h3>\n

Certifik\u00e1cia n\u00e1m d\u00e1va mo\u017enos\u0165 zaregistrova\u0165 technol\u00f3giu Telemon ako zdravotn\u00edcku pom\u00f4cku a m\u00f4\u017eeme za\u010da\u0165 rokova\u0165 s regul\u00e1torom, aby ju umo\u017enil financova\u0165 zo syst\u00e9mu verejn\u00e9ho zdravotn\u00e9ho poistenia. Pacienti tak bud\u00fa m\u00f4c\u0165 potenci\u00e1lne z\u00edska\u0165 pr\u00edspevok od zdravotnej pois\u0165ovne na jeho vyu\u017eitie pre r\u00f4zne spektrum diagn\u00f3z. Telemon sa t\u00fdm dost\u00e1va na \u00farove\u0148 be\u017enej zdravotn\u00edckej pom\u00f4cky, \u010do je jeden z k\u013e\u00fa\u010dov\u00fdch atrib\u00fatov aj pre roz\u0161\u00edrenie n\u00e1\u0161ho biznisu do zahrani\u010dia, preto\u017ee tento certifik\u00e1t predstavuje pomerne v\u00fdznamn\u00fa konkuren\u010dn\u00fa v\u00fdhodu.<\/p>\n

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Predpoklad\u00e1m, \u017ee z\u00edskanie certifik\u00e1tu je pomerne n\u00e1ro\u010dn\u00e1 z\u00e1le\u017eitos\u0165. Ak\u00e9 procesy ste museli absolvova\u0165?<\/h3>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n
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To je skuto\u010dne pravda. Certifik\u00e1cia je ve\u013emi zlo\u017eit\u00fd proces, a to z h\u013eadiska \u010dasu aj postupov. Najsk\u00f4r sme museli spracova\u0165 ve\u013emi podrobn\u00fa dokument\u00e1ciu v rozsahu stoviek str\u00e1n, ktorej obsahom boli smernice nielen o samotnom technickom rie\u0161en\u00ed, ale aj o jeho bezpe\u010dnosti, o postupoch overovania kvality a overovania s\u00faladu so samotnou regul\u00e1ciou. Bolo potrebn\u00e9 spravi\u0165 tie\u017e rizikov\u00fa anal\u00fdzu a pop\u00edsa\u0165 v\u0161etky procesy a postupy, ak\u00fdmi zabezpe\u010dujeme v\u00fdrobu, rozvoj a riadenie pr\u00edstupov, distrib\u00faciu a tie\u017e pou\u017e\u00edvanie tejto zdravotn\u00edckej pom\u00f4cky tak, aby sp\u013a\u0148ali po\u017eiadavky normy. Podmienkou MDR certifik\u00e1cie je aj to, \u017ee spolo\u010dnos\u0165 mus\u00ed ma\u0165 implementovan\u00fd aj syst\u00e9m mana\u017e\u00e9rstva kvality pod\u013ea ISO 13485, \u010do je \u0161pecifick\u00e1 norma pre v\u00fdrobu predaj a distrib\u00faciu zdravotn\u00edckych pom\u00f4cok.<\/p>\n

V \u010fal\u0161ej f\u00e1ze sme rie\u0161ili implement\u00e1ciu technick\u00e9ho rie\u0161enia, do ktor\u00e9ho sme museli doplni\u0165 niektor\u00e9 po\u017eiadavky regul\u00e1cie. I\u0161lo najm\u00e4 o nahradenie merac\u00edch zariaden\u00ed, ktor\u00e9 nemali certifik\u00e1t zdravotn\u00edckej pom\u00f4cky. No a napokon sme absolvovali samotn\u00fd audit notifikovanou spolo\u010dnos\u0165ou, ktor\u00e1 je opr\u00e1vnen\u00e1 ude\u013eova\u0165 certifik\u00e1ty MDR. Jeho s\u00fa\u010das\u0165ou bola kontrola dokument\u00e1cie, praktick\u00e1 sk\u00fa\u0161ka, overovanie presnosti meran\u00ed vit\u00e1lnych funkci\u00ed, technick\u00fdch aspektov a dodr\u017eiavania postupov pop\u00edsan\u00fdch v dokumentoch.<\/p>\n

Ako dlho trval cel\u00fd proces certifik\u00e1cie a ktor\u00e9 z uveden\u00fdch f\u00e1z boli pre v\u00e1s najn\u00e1ro\u010dnej\u0161ie?<\/h3>\n

Kompletn\u00e1 pr\u00edprava trvala takmer tri roky a s r\u00f4znou intenzitou sa na nej podie\u013ealo sedem \u013eud\u00ed. Pribli\u017ene tri \u0161tvrtiny \u010dasu zabrala len pr\u00edprava samotnej dokument\u00e1cie, tak\u017ee pr\u00e1ve t\u00e1to f\u00e1za bola \u010dasovo najn\u00e1ro\u010dnej\u0161ia. Vzh\u013eadom na to, \u017ee v priebehu vypracovania dokument\u00e1cie sa menili znenia s\u00favisiacich eur\u00f3pskych smern\u00edc, dokument\u00e1ciu sme museli nieko\u013ekokr\u00e1t prer\u00e1ba\u0165. Naopak, asi najmenej n\u00e1ro\u010dn\u00e1 bola implement\u00e1cia technick\u00e9ho rie\u0161enia, ke\u010f\u017ee sme od za\u010diatku v\u00fdvoja mysleli na to, \u017ee chceme MDR certifik\u00e1ciu absolvova\u0165.<\/p>\n

Relat\u00edvne zlo\u017eit\u00e1 bola v\u0161ak napr\u00edklad aj klasifik\u00e1cia zdravotn\u00edckej pom\u00f4cky. Pod\u013ea n\u00e1\u0161ho v\u00fdkladu legislat\u00edvy sme z h\u013eadiska rizikovosti ur\u010dili pre Telemon kateg\u00f3riu IIa. Na Slovensku v\u0161ak neexistuje in\u0161tit\u00facia, ktor\u00e1 by dok\u00e1zala rozhodn\u00fa\u0165 o zaraden\u00ed zdravotn\u00edckej pom\u00f4cky do konkr\u00e9tnej kateg\u00f3rie. Nakoniec sme potvrdenie spr\u00e1vnosti klasifik\u00e1cie rie\u0161ili na medzin\u00e1rodnej \u00farovni, \u010do n\u00e1s zdr\u017ealo pribli\u017ene 6 mesiacov.<\/p>\n

Ak\u00e9 s\u00fa podmienky pre obnovenie MDR certifik\u00e1tu? Je potrebn\u00e9 po \u010dase jeho platnos\u0165 aktualizova\u0165?<\/h3>\n

Certifik\u00e1t sa vyd\u00e1va sa platnos\u0165ou na 5 rokov. Ka\u017ed\u00fd rok prebieha tzv. recertifika\u010dn\u00fd audit. V pr\u00edpade v\u00e4\u010d\u0161\u00edch zmien syst\u00e9mu, napr\u00edklad po pridan\u00ed \u010fal\u0161\u00edch zariaden\u00ed, ich mus\u00edme certifika\u010dnej autorite ozn\u00e1mi\u0165, preto\u017ee tak\u00fdto z\u00e1sah si vy\u017eaduje nov\u00fa verziu certifik\u00e1tu. Ak by sme realizovali v\u00e1\u017ene zmeny, ktor\u00e9 by mohli so sebou prinies\u0165 nov\u00e9 rizik\u00e1 pri pr\u00e1ci so zdravotn\u00edckou pom\u00f4ckou, museli by sme po\u017eiada\u0165 o recertifik\u00e1ciu.<\/p>\n

Telemon je dnes jedna z m\u00e1la technol\u00f3gi\u00ed na svete, ktor\u00e1 m\u00e1 medzin\u00e1rodn\u00fa certifik\u00e1ciu na \u00farovni zdravotn\u00edckej pom\u00f4cky. Pl\u00e1nujete s t\u00fdmto rie\u0161en\u00edm expandova\u0165 aj na zahrani\u010dn\u00e9 trhy?<\/h3>\n

Samozrejme, v niektor\u00fdch krajin\u00e1ch u\u017e za\u010d\u00edname s prv\u00fdmi pilotn\u00fdmi projektmi. Pre medzin\u00e1rodn\u00fd rozvoj je z\u00e1sadn\u00e9 ma\u0165 nez\u00e1visl\u00e9 odborn\u00e9 potvrdenie, \u017ee technol\u00f3gia sp\u013a\u0148a vysok\u00e9 bezpe\u010dnostn\u00e9 \u0161tandardy. Pri zdravotn\u00edckych rie\u0161eniach je toto potvrdenie priam nevyhnutnos\u0165ou. Som r\u00e1d, \u017ee sa n\u00e1m dnes s certifikovan\u00fdm rie\u0161en\u00edm otv\u00e1raj\u00fa mo\u017enosti pre jeho \u0161irok\u00e9 vyu\u017eitie v klinickej praxi. Ver\u00edm, \u017ee na\u0161e rie\u0161enie bude dobre sl\u00fa\u017ei\u0165 pacientom po celom svete.<\/p>\n

\u010eakujeme.<\/h3>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

V m\u00e1ji 2024 z\u00edskalo telemedic\u00ednske rie\u0161enie Telemon prest\u00ed\u017eny MDR certifik\u00e1t. O\u00a0jeho v\u00fdzname sme sa porozpr\u00e1vali s \u013dubo\u0161om Petr\u00edkom, predsedom predstavenstva spolo\u010dnosti Goldmann Systems. Rie\u0161enie Telemon z dielne Goldmann Systems ned\u00e1vno z\u00edskalo MDR certifik\u00e1t. Pre\u010do je t\u00e1to certifik\u00e1cia d\u00f4le\u017eit\u00e1? Certifik\u00e1t MDR, \u010do je skratka pre Medical Device Regulation, je medzin\u00e1rodn\u00e9 osved\u010denie vyd\u00e1van\u00e9 nez\u00e1vislou certifika\u010dnou autoritou, ktor\u00e1 […]<\/p>\n","protected":false},"author":2,"featured_media":1658,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[27],"tags":[],"class_list":["post-1656","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-telemon"],"acf":[],"yoast_head":"\nV\u010faka medzin\u00e1rodn\u00e9mu certifik\u00e1tu MDR m\u00f4\u017ee rie\u0161enie Telemon sl\u00fa\u017ei\u0165 e\u0161te \u0161ir\u0161iemu spektru pacientov. Lubo\u0161 Petr\u00edk - Telemon<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/telemon.care\/sk\/vdaka-medzinarodnemu-certifikatu-mdr-moze-riesenie-telemon-sluzit-este-sirsiemu-spektru-pacientov-lubos-petrik\/\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"V\u010faka medzin\u00e1rodn\u00e9mu certifik\u00e1tu MDR m\u00f4\u017ee rie\u0161enie Telemon sl\u00fa\u017ei\u0165 e\u0161te \u0161ir\u0161iemu spektru pacientov. Lubo\u0161 Petr\u00edk - Telemon\" \/>\n<meta property=\"og:description\" content=\"V m\u00e1ji 2024 z\u00edskalo telemedic\u00ednske rie\u0161enie Telemon prest\u00ed\u017eny MDR certifik\u00e1t. O\u00a0jeho v\u00fdzname sme sa porozpr\u00e1vali s \u013dubo\u0161om Petr\u00edkom, predsedom predstavenstva spolo\u010dnosti Goldmann Systems. Rie\u0161enie Telemon z dielne Goldmann Systems ned\u00e1vno z\u00edskalo MDR certifik\u00e1t. Pre\u010do je t\u00e1to certifik\u00e1cia d\u00f4le\u017eit\u00e1? Certifik\u00e1t MDR, \u010do je skratka pre Medical Device Regulation, je medzin\u00e1rodn\u00e9 osved\u010denie vyd\u00e1van\u00e9 nez\u00e1vislou certifika\u010dnou autoritou, ktor\u00e1 […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/telemon.care\/sk\/vdaka-medzinarodnemu-certifikatu-mdr-moze-riesenie-telemon-sluzit-este-sirsiemu-spektru-pacientov-lubos-petrik\/\" \/>\n<meta property=\"og:site_name\" content=\"Telemon\" \/>\n<meta property=\"article:published_time\" content=\"2024-07-31T13:07:30+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-05T14:21:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/telemon.care\/wp-content\/uploads\/2026\/02\/petrik.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1680\" \/>\n\t<meta property=\"og:image:height\" content=\"1680\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"\u013dudmila Slez\u00e1kov\u00e1\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Autor\" \/>\n\t<meta name=\"twitter:data1\" content=\"\u013dudmila Slez\u00e1kov\u00e1\" \/>\n\t<meta name=\"twitter:label2\" content=\"Predpokladan\u00fd \u010das \u010d\u00edtania\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 min\u00fat\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/telemon.care\\\/sk\\\/vdaka-medzinarodnemu-certifikatu-mdr-moze-riesenie-telemon-sluzit-este-sirsiemu-spektru-pacientov-lubos-petrik\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/telemon.care\\\/sk\\\/vdaka-medzinarodnemu-certifikatu-mdr-moze-riesenie-telemon-sluzit-este-sirsiemu-spektru-pacientov-lubos-petrik\\\/\"},\"author\":{\"name\":\"\u013dudmila Slez\u00e1kov\u00e1\",\"@id\":\"https:\\\/\\\/telemon.care\\\/sk\\\/#\\\/schema\\\/person\\\/38dd92134beb968722163325134e886b\"},\"headline\":\"V\u010faka medzin\u00e1rodn\u00e9mu certifik\u00e1tu MDR m\u00f4\u017ee rie\u0161enie Telemon sl\u00fa\u017ei\u0165 e\u0161te \u0161ir\u0161iemu spektru pacientov. 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