Neuromodulation Devices and Associated Products

For the supply of Neuromodulation products and services and associated services that deliver safe, reliable and innovative solutions supporting positive patient outcomes ensuring continuity of supply, regulatory compliance and value beyond cost while enabling collaboration and continuous improvement. • ISO Certification: Tenderers must have ISO 9001: 2015 or BS EN ISO 13485:2016 or Medical Device Single Audit Program (MDAP) accredited by the United Kingdom Accreditation Service (or international equivalent) to cover all segments of the Tenderer’s and the product’s supply chain. This should include, but not be limited to, sales, manufacturing, storage and distribution ('ISO Certification')Link for acceptable alternatives https://iaf.nu/en/accreditation-bodies/ (‘Notified Bodies’)

• CE Certification and Declaration of Conformity certificates are required where applicable to be presented at submission stage of the tender.•Modern Slavery for Tenderers that have an annual turnover of at least £36 million must have a link to their modern slavery statement on their website
• Modern Slavery Assessment Tool (MSAT) Tenderers must have a score of 41% or above within 12months of the Tender Publication Date via https://supplierregistration.cabinetoffice.gov.uk/•Evergreen Sustainable Supplier Assessment – Tenderers will need to have completed the assessment and achieved Level 1 within 12months of the Tender Publication Date. Link for instructions and access for this assessment: https://www.england.nhs.uk/nhs-commercial/central-commercial-function-ccf/evergreen/
• Carbon Reduction Plan (CRP): Tenders must have a valid CRP link on their website that meets the requirements of PPN 006 as outlined in the PPN, OR Where Supplier has no website, the CRP is provided in PDF format that meets the requirements of PPN 006 as outlined in the PPN, OR Excused in exceptional circumstances
• Cyber Security: If you handle patient or personal data, or provide any IT systems, services, or devices you will be need to have a Cyber Security Essentials Plus Certificate.