{"status":"OK","data":{"advertisement":{"id":363958,"title":"REQUEST FOR QUOTATION No 1/2026","partial_offer_allowed":false,"publication_date":"2026-04-29","submission_deadline":"2026-05-08 23:59:59","planned_sign_date":null,"supplementary_orders":null,"terms_of_contract_change":"ESSENTIAL PROVISIONS OF THE AGREEMENT:\n1.\tThe successful Bidder will be obliged to conclude the contract on the terms and conditions set out in this Inquiry and Offer. \n2.\tIf the selected Bidder withdraws from the conclusion of the contract with the Ordering Party, the Ordering Party may conclude a contract with the next contractor whose offer will obtain the next highest number of points.\n3.\tThe Ordering Party reserves the right to change the terms of the contract concluded as a result of these proceedings:\na.\tin the event of a change in applicable regulations, if it is necessary to adapt the content of the Agreement to the current legal status (including applicable standards), \nb.\twhere the need for amendment is a consequence of amendments to guidelines, recommendations or decisions issued by the institution which granted the appropriations to finance the Agreement, \nc.\tin the event of a change in the rate of tax on goods for the assortment being the subject of the Agreement,\nd.\tterm of the contract \u2013 the Ordering Party reserves the right to change the expected date of the contract following changes in the scope of the signed agreement for co-financing the Project(s) (extension of the duration of the Project(s) or relevant stages of the Project(s), \ne.\twhen the changes concern the provision of additional services not covered by the basic contract (supplementary orders), the value of the changes will not exceed 50% of the contract value originally specified in the contract;\nf.\toccurrence of force majeure - the Ordering Party reserves the right to change the terms  of the contract concluded as a result of these proceedings also in the event of force majeure understood  as an event that fundamentally hinders  the performance of obligations under the co-financing agreement, which the parties could not foresee and prevent, as well as overcome through due diligence.\ng.\tin the case of conditions in accordance with Chapter 3.2.4. point 4 points b to e of the Guidelines on eligibility of expenditure for the years 2021-2027.\n4.\tThe Ordering Party reserves the right to impose contractual penalties on the Contractor:\na.\tIn the event of the Contractor's delay in fulfilling the obligations arising from the contract, including in the event of failure to meet the deadlines for performance of the contract, the Ordering Party may charge the Contractor a contractual penalty in the amount of statutory interest on the value of the contract to which the delay relates, for each day of delay, \nb.\tIf the Ordering Party withdraws from the contract for reasons attributable to the Contractor, the Contractor shall pay the Ordering Party a contractual penalty in the amount of 5% of the remuneration indicated in the contract.\nThe Contractor shall pay the contractual penalties on time and to the account specified by the Ordering Party. In the event of non-payment, the Ordering Party has the right to deduct contractual penalties from the remuneration due to the Contractor, without the need to obtain the Contractor's consent.\nIn the event of damage exceeding the amount of contractual penalties stipulated in the Agreement, the Ordering Party may claim supplementary compensation on general terms.","created_at":"2026-04-29 11:47:42","modified_at":"2026-05-09 00:00:41","contact_persons":[{"id":116345,"forename":"ALPHA OMEGA ENGINEERING ","surname":"Sp. z o.o.","phone_number":"","email":"areuvenny@luminxsmile.com","created_by":null,"created_at":"2026-04-29 11:47:42","modified_at":"2026-04-29 11:47:42","modified_by":null}],"orders":[{"id":588706,"estimated_value":null,"order_items":[{"id":662594,"description":"In connection with the implementation by the Ordering Party  of research and development project entitled \"Development of a new medical device - an integrated navigation cable for next-generation deep brain stimulation therapy\u201d applying for funding in the call no. FENG.01.01-IP.02-001/26  under the European Funds for Smart Economy program hereinafter  \"Project\" the  Ordering Party submits the inquiry regarding the implementation of the Research services.\n\nPart of the order: Part 1\nCPV name and code: 73110000-6 Research services.\n\nUs\u0142uga CRO (Contract Research Organization) w zakresie kierowania i przeprowadzania  bada\u0144 w projekcie. Projekt koncentruje si\u0119 na opracowaniu innowacyjnego systemu g\u0142\u0119bokiej stymulacji m\u00f3zgu (DBS), kt\u00f3ry integruje nawigacj\u0119 elektrofizjologiczn\u0105 bezpo\u015brednio z przewodem stymulacyjnym (Navigation Lead, dalej: NL). Rozwi\u0105zanie to ma na celu uproszczenie procedury DBS, skr\u00f3cenie czasu operacji i zmniejszenie koszt\u00f3w leczenia, a tym samym zwi\u0119kszenie dost\u0119pno\u015bci zaawansowanych terapii neuromodulacyjnych dla pacjent\u00f3w na ca\u0142ym \u015bwiecie, w tym tak\u017ce tych obj\u0119tych systemami opieki zdrowotnej o ograniczonych zasobach.\n\nPrace badawczo-rozwojowe w projekcie b\u0119d\u0105 realizowane zgodnie z wieloetapowym, iteracyjnym podej\u015bciem badawczym, integruj\u0105cym in\u017cynieri\u0119 biomedyczn\u0105, neurobiologi\u0119, analiz\u0119 sygna\u0142\u00f3w elektrofizjologicznych oraz metodologi\u0119 kliniczn\u0105. Podej\u015bcie to zapewnia systematyczn\u0105 weryfikacj\u0119 hipotez, minimalizacj\u0119 ryzyk technologicznych i zgodno\u015b\u0107 z normami regulacyjnymi (ISO 14708-3, ISO 10993-5/10/18). \n\nEtapy obejmuj\u0105 prototypowanie materia\u0142\u00f3w, projektowanie metody pozyskiwania i analizy sygna\u0142\u00f3w, rozw\u00f3j algorytm\u00f3w nawigacji, walidacj\u0119 przedkliniczn\u0105 oraz kliniczn\u0105, z ci\u0105g\u0142\u0105 ocen\u0105 wynik\u00f3w (Kamienie milowe) i iteracjami na podstawie danych empirycznych (KPI: trafno\u015b\u0107 nawigacji >90%, redukcja czasu operacji >30%).\n\n1.\tPrototypowanie i badania materia\u0142\u00f3wZaprojektowane zostan\u0105 prototypy elektrod DBS (d\u0142ugo\u015b\u0107 30-40 cm, \u015brednica 1,27 mm) z 4 mikrokontaktami oraz 8 makrokontaktami(rozdzielczo\u015b\u0107 20-50 \u03bcm, impedancja <1 k\u03a9 przy 1 kHz) na bazie elastycznych polimer\u00f3w (PDMS z parylenem C, modu\u0142 Younga 1-5 MPa). Proces obejmie nast\u0119puj\u0105ce kroki:- Modelowanie CAD (SolidWorks) i symulacje FEA (COMSOL Multiphysics: napr\u0119\u017cenia <10 MPa).- Formowanie, zwijanie, spawanie laserowe i ablacja laserowa.- Etapowanie: 3 iteracje prototyp\u00f3w (v1-v3).\n2.\tTesty:- Stabilno\u015b\u0107 mechaniczna: 10^6 cykli zginania (k\u0105t 90\u00b0, 1 Hz).- Przyspieszone starzenie: 37\u00b0C, PBS pH 7,4, 5000 h (ekwiwalent 5 lat; Grill i in., Annual Review of Biomedical Engineering, 2021).- Biokompatybilno\u015b\u0107: test MTT (IC50 >90%), histologia SEM (adhezja neuron\u00f3w >80%).\n3.\tPozyskiwanie sygna\u0142\u00f3w elektrofizjologicznych i opracowanie algorytmu nawigacji. \n4.\t-Rejestracja sygna\u0142\u00f3w z przewodu nawigacyjnego w laboratoriach Wnioskodawcy, a tak\u017ce w niekt\u00f3rych testach na zwierz\u0119tach.- Analiza sygna\u0142\u00f3w: filtracja CAR (wsp\u00f3lna \u015brednia referencja), detekcja kolc\u00f3w (pr\u00f3g 4\u03c3, sortowanie PCA >95% izolacja), spektralna LFP (transformata falkowa, pasma theta 4-8 Hz, beta 13-30 Hz, gamma 60-200 Hz).3\n5.\tAlgorytm nawigacji: G\u0142\u00f3wny algorytm nawigacji zostanie opracowany na elektrodzie AP. Nast\u0119pnie zostanie on dostosowany do NL, aby dopasowa\u0107 go do jego konfiguracji. G\u0142\u00f3wnym zadaniem, po przeniesieniu algorytmu, b\u0119dzie zastosowanie automatyzacji opisanej powy\u017cej (dostosowanie nawigacji do ci\u0105g\u0142ego ruchu elektrody i wdro\u017cenie w pe\u0142ni automatycznego procesu potwierdzania stymulacji).Walidacja algorytmu zostanie przeprowadzona poprzez wykonanie przypadk\u00f3w DBS, w kt\u00f3rych NL b\u0119dzie u\u017cywany jako elektroda ostra (a nie jako implant), w celu potwierdzenia dok\u0142adno\u015bci. B\u0119dzie to nieformalny etap opracowywania algorytmu w celu jego optymalizacji pod k\u0105tem najwy\u017cszej dok\u0142adno\u015bci.\n6.\tWalidacja przedkliniczna\n\nBadanie zostanie przeprowadzone zgodnie z:- 21 CFR Cz\u0119\u015bci 50, 56, 812- ISO 14155- ICH-GCP- zatwierdzeniem FDA IDE oraz- obowi\u0105zuj\u0105cymi lokalnymi wymogami regulacyjnymi i komisji etycznych. Liczebno\u015b\u0107 pr\u00f3by w tym badaniu zosta\u0142a okre\u015blona na podstawie analizy skuteczno\u015bci opartej na odpowiedzi na leczenie, zgodnie z definicj\u0105 g\u0142\u00f3wnego  punktu ko\u0144cowego w protokole badania. Sukces leczenia definiuje si\u0119 jako osi\u0105gni\u0119cie co najmniej 30% poprawy w stosunku do warto\u015bci wyj\u015bciowej w g\u0142\u00f3wnym pomiarze skuteczno\u015bci po 12 miesi\u0105cach obserwacji.\nZaanga\u017cowanie CRO jest uzasadnione ze wzgl\u0119du na z\u0142o\u017cono\u015b\u0107 bada\u0144 klinicznych wyrob\u00f3w medycznych klasy III, wymogi regulacyjne MDR 2017/745 oraz ograniczone kompetencje wewn\u0119trzne przedsi\u0119biorstwa produkcyjnego w zakresie prowadzenia pr\u00f3b klinicznych. \n\n\uf0d8\tThe Ordering Party does not allow the possibility of submitting partial offers (1 part of the subject of the order). \n\uf0d8\tThe Ordering Party does not allow the possibility of submitting variant offers.\n\nRULES OF ORDER EXECUTION:\n\n\uf0d8\tPAYMENT TERMS: payment deadline for an invoice of not less than 30 calendar days from receipt of correctly issued invoice.  Invoices will be issued based on faultless acceptance protocols for a given task (of deliverables) signed by both parties to the contract. The payment deadline is an admission condition, tenders indicating a shorter deadline will be rejected. Payments will be made according to schedule that will be agreed after signing the agreement. No advance payments are envisaged.\n\n\uf0a7\tAGREEMENT DATE:  Orders under the contract will be executed from the signing of the contract until the date of completion of the relevant stages of the Projects. In the event of prolonging the completion date of any of the Projects or the relevant stage of the Project, the framework agreement may be extended following changes in the applications for co-financing of Projects.    \n\nPLACE, DATE AND PROCEDURE FOR SUBMISSION OF TENDERS:\n1.\tOffers must be submitted via Baza konkurcyjnosci website: https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl/ by  16:00 CET at 30.04.2026. \n2.\tThe offer together with attachments should be made in Polish or English.  \n3.\tThe offer should be prepared in accordance with the form constituting Appendix 1 to this inquiry.\n4.\tThe offer must be signed by persons authorized to represent the Bidder in accordance with the registration document or in accordance with the power of attorney granted. It is allowed to use an electronic signature (including a qualified electronic signature), a trusted signature (trusted profile) or provide a scan of a handwritten offer.\n5.\tTimely submission of an offer is determined by the date of submission of the offer via the Competitiveness Database (BK2021).\n6.\tThe costs related to the preparation of the offer shall be borne by the Bidder.\n7.\tSubmitting an offer is tantamount to accepting without reservations the content of this RFQ together with attachments.\n8.\tIn the course of comparing and evaluating tenders, the Ordering Party shall correct obvious clerical and accounting errors in the tenders, at the same time informing the Bidder about the content of the amendment. If the Bidder does not agree to correct the errors within the time limit indicated by the Ordering Party, its offer shall be rejected.\n9.\tThe part of the offer that contains information constituting a trade secret within the meaning of the provisions on combating unfair competition, and the Contractor reserves their confidentiality, should be described as \"Confidential\". The Ordering Party shall not be liable for the disclosure of information constituting a trade secret provided to it by the Contractor contrary to the provisions of this subsection. A trade secret is understood as technical, technological, organizational information of the enterprise not disclosed to the public or other information of economic value for which the entrepreneur has taken the necessary measures to maintain their confidentiality, in accordance with the Act of 16 April 1993 on combating unfair competition (consolidated text: Journal of Laws of 2022, item 1233; binding text).\n10.\tAn offer that does not meet the requirements set out above shall be rejected, subject to the provisions on the possibility of allowing the Ordering Party to call on Bidders who have not submitted the required statements, or who have not submitted registration documents or powers of attorney, or who have submitted the above-mentioned statements and documents containing errors or incomplete or raising doubts indicated by the Ordering Party to their submission, supplementation or correction within the prescribed period,  or to provide explanations, unless despite their submission the Bidder's offer would be rejected or the procedure would be subject to annulment. If the Bidder does not submit, supplement or correct the above-mentioned statements or documents within the time limit set by the Ordering Party, its offer shall be rejected. Subsequently, the committee will evaluate the offers in accordance with point IV. \n\nOFFER VALIDITY PERIOD: \nThe offer should include its validity period at least until  30 September 2026. \nThe Ordering Party may request the Bidders to agree to extend the period of validity of the offer by the time needed to conclude the contract. \n","warranty_period":null,"cpv_items":[{"id":8514,"code":"73110000-6","name":"Us\u0142ugi badawcze"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":null,"poviat":null,"commune":null,"locality":null,"created_by":null,"created_at":"2026-04-29 11:47:42","modified_at":"2026-04-29 11:47:42","modified_by":null,"id":753855,"type":{"id":2,"name":"ca\u0142a Polska"},"group_uuid":"35543f79-c9ea-4bdf-bbb3-4f2d2d1a7409"}],"participation_conditions":[{"id":1892034,"description":"The award of the contract may be applied for by Bidders who:\na.\thave the authority to carry out a specific activity or activity, if the law imposes an obligation to have such powers;\nb.\tcarry out activities consistent with the description of the subject of the contract;\nc.\tthey have the necessary knowledge and experience and have the technical capacity and persons capable of performing the contract:","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2026-04-29 11:47:42","modified_at":"2026-04-29 11:47:42","modified_by":null,"group_uuid":"022d68df-3238-49bd-8f35-0a73e9c31471"},{"id":1892035,"description":"d.\tare in an economic and financial situation ensuring the performance of the contract;\ne.\tare not in liquidation or have not been declared bankrupt;\nf.\tare not in arrears with the payment of public law fees, taxes or social or health insurance contributions \u2013 the Bidder shall submit a statement that it has no arrears due to the above-mentioned receivables (public law fees, taxes, social security or health insurance contributions);\ng.\thave not been legally convicted of an offence committed in connection with the procurement procedure, bribery offence, a crime against economic turnover or another crime committed in order to obtain financial benefits  - concerns a partner in a general partnership, partner or member of the management board of a partner company, a general partner of a limited partnership and a limited joint-stock partnership; a member of the management body of a legal person.","type":{"id":5,"name":"Sytuacja ekonomiczna i finansowa"},"created_by":null,"created_at":"2026-04-29 11:47:42","modified_at":"2026-04-29 11:47:42","modified_by":null,"group_uuid":"f9f40099-170f-40fa-b715-cb01ee512ee2"},{"id":1892036,"description":"h.\tare not related personally or financially with the Ordering Party (mutual relations between the Ordering Party or persons authorized to incur obligations on behalf of the Ordering Party or persons performing activities related to the selection procedure of the Contractor and the Bidder on behalf of the Ordering Party).\nCapital or personal ties shall be understood as mutual relations between the Ordering Party or persons authorized to incur obligations on behalf of the Ordering Party or persons performing activities on behalf of the Ordering Party related to the preparation and conduct of the procedure for selecting the Contractor and the Contractor, consisting in particular in:\n\uf02d\tparticipation in the company as a partner in a civil law partnership or partnership, holding at least 10% of shares (unless a lower threshold results from the law), performing the function of a member of a supervisory or management body, proxy, proxy, \n\uf02d\tbeing married, by kinship or affinity in a direct line, by kinship or affinity in the collateral line up to the second degree, or by virtue of adoption, guardianship or guardianship, or cohabitation with the contractor, its legal representative or members of the management or supervisory bodies of the economic operators applying for the award of the contract, \n\uf02d\tremaining in such a legal or factual relationship with the economic operator that there is reasonable doubt as to their impartiality or independence in connection with the procurement procedure.\ni.\tare not subject to exclusion pursuant to Article 7(1) of the Act of 13 April 2022 on special solutions for counteracting support for aggression against Ukraine and serving the protection of national security (Journal of Laws, item 835).\nThe above conditions should be confirmed by a statement - Appendix No. 1 to this inquiry.\n\nj.\thave achieved annual revenues from services similar to the subject of the contract in at least one of the last three completed fiscal years at a level not lower than the estimated value of the contract, or another amount proportionate to the scope of the services.","type":{"id":7,"name":"Dodatkowe warunki udzia\u0142u"},"created_by":null,"created_at":"2026-04-29 11:47:42","modified_at":"2026-04-29 11:47:42","modified_by":null,"group_uuid":"a7349c3c-2e05-473a-8869-f0056c636ef0"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":4,"name":"Us\u0142ugi badawcze"},"created_by":null,"created_at":"2026-04-29 11:47:42","modified_at":"2026-04-29 11:47:42","modified_by":null,"group_uuid":"1a364ece-192b-4ac1-8c22-a0eb27b11bfa"}],"evaluation_criteria":[{"id":1059972,"price_criterion":true,"description":"Criterion: Net price (\"C\") \u2013 weight: 100 % (10 points)","created_by":null,"created_at":"2026-04-29 11:47:42","modified_at":"2026-04-29 11:47:42","modified_by":null,"group_uuid":"c3db9e0c-f196-44cb-ab24-cf07c5f3f01a"}],"is_variant":false,"title":"Us\u0142uga badawcza","order_node":{"id":438196},"created_by":null,"created_at":"2026-04-29 11:47:42","modified_at":"2026-04-29 11:47:42","modified_by":null}],"created_by":{"id":118718,"contact_persons":[]},"modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":2,"label":"PUBLISHED","name":"Opublikowane"},"advertiser_address_details":{"name":"ALPHA OMEGA ENGINEERING Sp. z o.o.","identification_number_type":"nip","identification_number":"5273209931","address":{"country":"Polska","voivodeship":"mazowieckie","poviat":"Warszawa","commune":"Wola","locality":"Warszawa","created_by":{"id":118718,"contact_persons":[]},"created_at":"2026-04-29 11:47:42","modified_at":"2026-04-29 11:47:42","modified_by":{"id":118718,"contact_persons":[]},"id":1026627,"street":"Wolska","number_description":"58/1","postcode":"01-134"},"created_by":{"id":118718,"contact_persons":[]},"created_at":"2026-04-29 11:47:42","modified_at":"2026-04-29 11:47:42","modified_by":{"id":118718,"contact_persons":[]},"id":364954},"advertisement":{"id":271506,"number":"2026-118718-271506","publication_date":"2026-03-30","created_by":{"id":118718,"contact_persons":[]},"created_at":"2026-03-30 16:16:25","modified_at":"2026-05-09 00:00:41","modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":3,"label":"CLOSED","name":"Zamkni\u0119te"},"all_available_version_ids":[358371,363958],"enrollment":{"id":69973,"name":"\"Development of a new medical device - an integrated navigation cable for next-generation deep brain stimulation therapy\u201d","number":"001/26","activity":{"created_by":null,"created_at":"2023-02-01 09:22:25","modified_at":"2023-02-01 09:22:25","modified_by":null},"region":null,"institution":{"created_by":null,"created_at":"2023-02-01 09:28:01","modified_at":"2023-02-01 09:28:01","modified_by":null},"full_number":"FENG.01.01-IP.02-001/26","perspective":{},"programme":{"created_by":null,"created_at":"2023-02-01 09:21:41","modified_at":"2023-02-01 09:21:41","modified_by":null},"priority":{"created_by":null,"created_at":"2023-02-01 09:21:51","modified_at":"2023-02-01 09:21:51","modified_by":null},"type":"enrollment","created_by":null,"created_at":"2026-03-30 16:09:25","modified_at":"2026-03-30 16:09:25","modified_by":null},"projects":[],"is_author":false,"is_admin":false},"attachments":[{"origin":{"id":358371,"publication_date":"2026-03-30"},"id":2430595,"name":"REQUEST_AO_FINAL.docx","file":{"id":2698976,"name":"REQUEST_AO_FINAL.docx","created_at":"2026-04-29 11:47:42","created_by":{"forename":"El\u017cbieta","surname":"Niewiarowska"},"uri":"/api/files/2698976"},"group_uuid":"7899898e-8c87-4537-9d79-a100b6a754e9"}]},"dictionaries":{"announcement_status_draft":1,"announcement_status_published":2},"favorite":null,"badge":null,"offer_set_badge_count":null,"question_badge_count":null}}