{
"id": 128508,
"procurementProjectId": 88103,
"noticeNumber": "2023-128508",
"reducedTimeLimitsForReceiptOfTenders": false,
"corrigendumAdditionalInformation": [],
"creatorSystem": "Cloudia Kilpailutus",
"type": 100,
"legalBasis": "32014L0024",
"project": {
"id": 88103,
"title": "L\u00e4\u00e4kinn\u00e4llisten laitteiden prosessin konsultaatiopalvelut",
"contractType": 2,
"procurementCategory": 1,
"jointProcurement": false,
"procurementLaw": [],
"centralPurchasing": false,
"coPurchasers": [],
"validationState": 0,
"organisation": {
"id": "42e326b7-5fa5-4c29-2d4e-08d78deb351a",
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"nationalRegistrationNumber": "2292633-0",
"nutsCodes": [
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"country": "FI"
},
"email": "[email protected]",
"mainUrl": "https:\/\/www.istekki.fi\/",
"validationState": 0
},
"contractingAuthorityType": 64,
"otherContractingAuthorityType": "Julkisomisteinen osakeyhti\u00f6",
"contractingType": 0,
"mainActivity": 1024,
"otherMainActivity": "Informaatio- sek\u00e4 terveyden ja hyvinvoinnin teknologian palvelut",
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"identifierMissing": false,
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"lotsMaxAwardedQuantity": 0,
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"lotCombinationPossibleDescription": [],
"validationState": 0
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"name": "(4) Tutkimus- ja kehityspalvelut ja niihin liittyv\u00e4t konsulttipalvelut",
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"name": "Terveys- ja turvallisuuskysymyksi\u00e4 koskevat konsulttipalvelut",
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"descrProcurement": [
"Katso kohta \"II.1.4) Lyhyt kuvaus\"."
],
"disagreeAwardCriteriaToBePublished": false,
"awardCriteria": {
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"qualityCriteria": [],
"costCriteria": [],
"priceCriterion": {},
"criterion": [],
"criteriaStatedInProcurementDocuments": false
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"optionType": 0
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"tendersMustBePresentedAsElectronicCatalogs": false,
"euFunds": {
"procurementRelatedToEuProgram": false
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"awardContract": {
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"noAwardedContract": {
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"originalNoticeSentVia": 0
},
"awardedContracts": []
},
"validationState": 0
}
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"communicationInformation": {
"procurementDocumentsAvailable": 0,
"additionalInformation": 2,
"additionalInformationAddress": {
"officialName": "Hansel Oy",
"nutsCodes": [
"FI1B1"
],
"postalAddress": {
"town": "Helsinki",
"country": "FI"
},
"email": "[email protected]",
"mainUrl": "https:\/\/www.hansel.fi\/",
"validationState": 0
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"validationState": 0
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"electronicCommunicationRequiresSpecialTools": false,
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"email": "[email protected]"
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"procurementObject": {
"shortDescription": [
"Istekki Oy (Tilaaja) on kehitt\u00e4nyt l\u00e4\u00e4kinn\u00e4llisten laitteiden valmistukseen liittyv\u00e4\u00e4 laatuj\u00e4rjestelm\u00e4\u00e4 ja aloittanut l\u00e4\u00e4kinn\u00e4llisten laitteiden (sovellukset) valmistuksen. T\u00e4h\u00e4n liittyen Tilaaja suunnittelee l\u00e4\u00e4kinn\u00e4llisten laitteiden valmistuksen regulaatioon (Medical Device Regulation, MDR) ja laatuj\u00e4rjestelm\u00e4\u00e4n (ISO 13485) liittyv\u00e4n konsultaation hankkimista. Konsultaatiota tullaan hy\u00f6dynt\u00e4m\u00e4\u00e4n etenkin l\u00e4\u00e4kinn\u00e4llisten laitteiden valmistuksen toimintamallien ja laatuj\u00e4rjestelm\u00e4n (ISO 13485) jatkuvaan kehitt\u00e4miseen sek\u00e4 uusien CE-merkitt\u00e4vien l\u00e4\u00e4kinn\u00e4llisten laitteiden kehitt\u00e4misen tueksi.",
"",
"Hankittavaa konsultaatiopalvelua k\u00e4ytet\u00e4\u00e4n mm. seuraaviin teht\u00e4viin liittyen: ",
"\u2022 ISO 13485 mukaisen laatuj\u00e4rjestelm\u00e4n kehitys ",
"\u2022 Tuotteen teknisen tiedoston sis\u00e4ll\u00f6n konsultointi CE merkint\u00e4\u00e4 varten ",
"\u2022 IEC 62304 mukaisen sw kehitysprosessin kehitys ja ketter\u00e4n kehitt\u00e4misen mallit ",
"\u2022 Verifiointi ja validointiprosessit tuotteelle ",
"\u2022 ISO 14971 mukainen riskienhallinta ",
"\u2022 Kliinisen arvioinnin prosessien m\u00e4\u00e4rittely ja kehitys ",
"\u2022 Tietoj\u00e4rjestelmien validointi ",
"\u2022 Eudamed rekister\u00f6innit sek\u00e4 UDI \u2013tunnisteeseen liittyv\u00e4t prosessit ja vaatimukset ",
"\u2022 Ilmoitetun laitoksen kanssa asioinnissa avustaminen, sertifiointiprosessi ",
"\u2022 L\u00e4\u00e4kinn\u00e4llisten laitteiden tunnistaminen ja luokittelu ",
"\u2022 Olemassa olevien tuotteiden arviointi MDR:n kannalta ",
"\u2022 Tuotekehitysprosessin tuotekatselmointien konsultointi laatu ja MDR:n n\u00e4k\u00f6kulmasta ",
"\u2022 Vaatimuksenmukaisuusvakuutuksen laatiminen ",
"\u2022 L\u00e4\u00e4kinn\u00e4llistenlaitteiden tietoturva IEC 81001-5-1 standardin mukaan ",
"",
"Hankinta tullaan jakamaan osa-alueisiin. Osa-alueet tarkentuvat valmistelun aikana.",
"",
"Katso tarkemmat lis\u00e4tiedot markkinavuoropuheluun liittyen t\u00e4m\u00e4n ennakkotietoilmoituksen kohdasta \"VI.3) Lis\u00e4tiedot\"."
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"name": "(4) Tutkimus- ja kehityspalvelut ja niihin liittyv\u00e4t konsulttipalvelut",
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"tendererHasToIndicateChange": false,
"caMayOblige": false,
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"renewals": {
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"obligationToIndicateNamesAndProfessionalQualifications": false,
"validationState": 0
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"restrictedToShelteredWorkshops": false,
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"electronicOrderingUsed": false,
"electronicInvoicingUsed": false,
"electronicPaymentUsed": false,
"additionalInformation": [
"T\u00e4m\u00e4 ilmoitus on ennakkotietoilmoitus (tietopyynt\u00f6). T\u00e4ll\u00e4 ilmoituksella ei pyydet\u00e4 tarjouksia. ",
"",
"Ennakkotietoilmoitukseen liittyy kutsu markkinakartoitukseen (j\u00e4ljemp\u00e4n\u00e4 markkinavuoropuhelu), jossa hankinnasta kiinnostuneilla tarjoajilla on mahdollisuus k\u00e4yd\u00e4 hankintaa koskevaa vuoropuhelua hankintayksik\u00f6n kanssa. Ennakkotietoilmoitukseen vastaaminen tai vastaamatta j\u00e4tt\u00e4minen ei est\u00e4 mahdolliseen tarjouskilpailuun osallistumista. ",
"",
"Ilmoittautumisohje markkinavuoropuheluun:",
"",
"Hankinnasta kiinnostuneita yrityksi\u00e4 pyydet\u00e4\u00e4n ilmoittautumaan viimeist\u00e4\u00e4n 30.6.2023 s\u00e4hk\u00f6postitse osoitteeseen [email protected] seuraavin tiedoin:",
"",
"- Viestin aihe\/otsikko:",
"\"L\u00e4\u00e4kinn\u00e4llisten laitteiden prosessin konsultaatiopalvelut - Markkinavuoropuhelu\"",
"",
"- Viestin sis\u00e4lt\u00f6:",
"1) Yrityksen nimi ja y-tunnus,",
"2) Yhteyshenkil\u00f6n nimi ja s\u00e4hk\u00f6postiosoite ",
"3) Lyhyt kuvaus yrityksest\u00e4 ja kokemuksesta konsultaatiopalveluiden tuottajana",
"",
"Ilmoittautuneiden henkil\u00f6tietoja k\u00e4ytet\u00e4\u00e4n vain t\u00e4h\u00e4n kilpailutukseen liittyviin yhteydenottoihin. Henkil\u00f6tietoja s\u00e4ilytet\u00e4\u00e4n vain kyseisen kilpailutuksen valmistelun ja mahdollisen siihen liittyv\u00e4n tarjouskilpailun ajan.",
"",
"Markkinavuoropuhelun toteutus: ",
"",
"Hankintayksikk\u00f6 voi l\u00e4hett\u00e4\u00e4 kilpailutuksen luonnosmateriaaleja kommenttikierrokselle markkinavuoropuheluun mukaan ilmoittautuneille yrityksille. Lis\u00e4ksi hankintayksikk\u00f6 varaa mahdollisuuden kutsua markkinavuoropuheluun ilmoittautuneita yrityksi\u00e4 (et\u00e4)tapaamisiin. ",
"",
"Markkinavuoropuheluun osallistuneille ei makseta korvausta osallistumisesta. ",
"",
"Hansel Oy toimii kilpailutuksessa konsultoivassa roolissa."
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"datePublished": "2023-05-14T12:20:07.610294",
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