Brief: Pasco Medical Limited are seeking tenders from Companies with the capability to perform medical device electrical safety and EMC testing according to IEC 60601 family of standards. The medical device is a small portable unit designed for early detection of eye diseases and has a visible light illumination system based on a rotating assembly.
Further details of instrument functionality and capabilities will be provided upon request.
Scope: Electrical Safety testing of Medical Device
The project requires a service provider that can address the following issues
- Safety testing for Ophthalmic Devices according to IEC/ EN 60601-1
- Risk management compliance check according to ISO 14971
- EMC Test Plan covering requirements of IEC 60601-1-2:2015+ A1:2021
- EMC technical report
- Issue of EMC Test Certificate upon successful completion and passing of testing program
- Usability assessment for Ophthalmic Devices according to IEC 60601-1-6
- Optional radio testing and test report
Services are required to be complete by 1 June 2023.
The responses will be reviewed based on the follow criteria:
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- Design – the proposed activities for the service provision
- Experience – a proven record of delivery relevant to the brief
- Capability/responsiveness – the ability to commence the project within 1 month of appointment and complete the project by end date
- Value for Money – the ability to provide the project to pre-determined budgets and at benchmark rates for equivalent technologies
- Cultural fit – the ability to relate to the policies and work practices
- Recognised medical device test house with proven track record and appropriate certification
Proposals are required by 10 March 2023. To submit a proposal please contact Andrew by email at zwang01@pascomedical.co.uk