Tender

KCL-00001286 Regulatory support and CE Marking certification for a digital medical device

KING'S COLLEGE LONDON

This public procurement record has 1 release in its history.

Tender

18 Nov 2020 at 14:31

Tender Notice
Summary of the contracting process

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.

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Notice Information

Notice Title

KCL-00001286 Regulatory support and CE Marking certification for a digital medical device

Notice Description

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

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-f16f2875-e8db-4765-9eb4-798912149b75
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/967a2732-7775-4710-84b5-6564b2a763b5
Current Stage
Tender
All Stages
Tender

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV Divisions

72 - IT services: consulting, software development, Internet and support

CPV Codes

72000000 - IT services: consulting, software development, Internet and support

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
18 Nov 20205 years ago
Submission Deadline
2 Dec 2020Expired
Future Notice Date
Not specified
Award Date
Not specified
Contract Period
1 Jan 2021 - 1 May 2025 4-5 years
Recurrence
Not specified

Notice Status

Tender Status
Active
Lots Status
Not Specified
Awards Status
Not Specified
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
KING'S COLLEGE LONDON
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
LONDON
Postcode
WC2R 2LS
Post Town
Central London
Country
England
Major Region (ITL 1)
TLI London
Basic Region (ITL 2)
TLI3 Inner London - West
Small Region (ITL 3)
TLI35 Westminster and City of London
Delivery Location
TLI London
Local Authority
Westminster
Electoral Ward
St James's
Westminster Constituency
Cities of London and Westminster

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts. 

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