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

Tender 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