--- title: "KCL-00001286 Regulatory support and CE Marking certification for a digital medical device" ocid: "ocds-b5fd17-f16f2875-e8db-4765-9eb4-798912149b75" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-f16f2875-e8db-4765-9eb4-798912149b75" markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-f16f2875-e8db-4765-9eb4-798912149b75.md" json_url: "https://d3tenders.com/contract/ocds-b5fd17-f16f2875-e8db-4765-9eb4-798912149b75.json" source: "Contracts Finder" current_stage: "Tender" buyer: "KING'S COLLEGE LONDON" published: "2020-11-18" --- # KCL-00001286 Regulatory support and CE Marking certification for a digital medical device Buyer: KING'S COLLEGE LONDON Current stage: Tender OCID: ocds-b5fd17-f16f2875-e8db-4765-9eb4-798912149b75 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-b5fd17-f16f2875-e8db-4765-9eb4-798912149b75) [Download OCDS JSON](https://d3tenders.com/contract/ocds-b5fd17-f16f2875-e8db-4765-9eb4-798912149b75.json) ## Summary King's College London is seeking qualified suppliers to participate in a tender for "Regulatory support and CE Marking certification for a digital medical device." The procurement falls under the IT services industry category, specifically focusing on consulting and software development. The tender period ends at 11:59 AM on 2nd December 2020, with the contract anticipated to commence on 1st January 2021 and concluding on 1st May 2025. Interested suppliers must demonstrate specialized experience in regulatory advice pertaining to medical devices and CE marking compliance. Applications should be submitted via the university's e-tendering portal by the specified deadline. This tender presents a significant opportunity for businesses specialising in regulatory compliance and consulting services within the medical device sector. Companies with expertise in EU Medical Device Regulations and experience in supporting digital medical devices through the regulatory process will be particularly well-suited to compete. The successful provider will be responsible for ensuring compliance throughout the project and preparing necessary documentation for CE marking, thereby enhancing their reputation and securing valuable experience in the growing field of digital health innovation. ## Notice Register interest in the opportunity and apply ONLY if you are a supplier who has proven previous and specialist experience in providing regulatory advice and support in regards to Medical Device Regulations and CE Marking Certification. It is imperative that the provider has evidenced expertise to support digital medical devices across the different stages of the regulatory process. King's College London is interested in inviting companies to express an interest for the present opportunity. The university is keen in identifying providers with expertise in the following areas where the project will be seeking assistance with two main activities: 1) Ensuring compliance with the EU Medical Device Regulations (and the incoming UK regulations) throughout the entire duration of the project. This will require, for example, performing a gap assessment, developing a compliance pathway, performing a risk assessment and helping King's put a quality management system in place. This will be required before the start of the validation trial. 2) Drafting the documentation required to apply for CE marking (and UK equivalent). This will be required at the end of the validation trial. A Scope of Services is enclosed to the exercise to give details of the requirement in its present form. Additional information: Submission Due Date and Instructions: Please note that all interested Suppliers will need to submit their response to the present opportunity by 12:00 noon on Wednesday, 02/12/2020 via King's e-tendering portal, In-Tend (project reference: KCL-00001286). Please refer to the relevant link enclosed within the Scope of Services. Is a Recurrent Procurement Type? : No ## Key Details | Field | Value | | --- | --- | | Publication source | Contracts Finder | | Latest notice | https://www.contractsfinder.service.gov.uk/Notice/967a2732-7775-4710-84b5-6564b2a763b5 | | Notice type | Tender Notice | | Procurement type | Standard | | Procurement category | Services | | Procurement method | Not Specified | | Procurement method details | Other - | | Tender suitability | Not specified | | Awardee scale | Not specified | | All stages | Tender | ## Dates | Field | Value | | --- | --- | | Publication date | 18 Nov 2020 | | Submission deadline | 2 Dec 2020 | | Future notice date | Not specified | | Award date | Not specified | | Contract period | 1 Jan 2021 - 1 May 2025 | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | Not specified | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Active | | Lots status | Not specified | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | KING'S COLLEGE LONDON | | Locality | LONDON | | Post town | Central London | | Postcode | WC2R 2LS | | Country | England | | ITL 1 | TLI London | | ITL 2 | TLI3 Inner London - West | | ITL 3 | TLI35 Westminster and City of London | | Local authority | Westminster | | Electoral ward | St James's | | Westminster constituency | Cities of London and Westminster | | Delivery location | TLI London | ## CPV Codes ### Divisions - 72 - IT services: consulting, software development, Internet and support ### Codes - 72000000 - IT services: consulting, software development, Internet and support ## Release History - 18 Nov 2020 at 14:31 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/967a2732-7775-4710-84b5-6564b2a763b5 ## Documents - https://www.contractsfinder.service.gov.uk/Notice/967a2732-7775-4710-84b5-6564b2a763b5 18th November 2020 - Opportunity notice on Contracts Finder - https://in-tendhost.co.uk/kcl/aspx/ Additional information on how to apply for this contract ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-b5fd17-f16f2875-e8db-4765-9eb4-798912149b75. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-f16f2875-e8db-4765-9eb4-798912149b75.json.