Regulatory Compliance Services for Medical Devices
Details
- Buyer
- NHS England
- Supplier(s)
- SCARLET GLOBAL HOLDINGS LTD
- Value
- £75,000
- Duration
- 9 months
- Topic
- Health services
- Published
- 19 June 2026
- Source
- uk:find_a_tender
Tender description
The procurement covers regulatory compliance services for medical devices, specifically the engagement of a UK Approved Body to conduct a two-stage external audits (Stage 1 and Stage 2) in line with agreed timelines, to urgently achieve ISO 13485 Quality Management System certification. The deliverables will ensure that our medical devices are safe, effective, reliable and meet internationally recognized standard. With the UK medical device regulations set to change in Spring 2026, several currently self-certified, low-risk SaMDs will be reclassified as higher-risk devices. This means external certification by a UK Approved Body (e.g., BSI) will become mandatory. Failure to achieve this will result in an “innovation freeze,” preventing the introduction of new or updated SaMDs and AIaMDs, and exposing NHS England to significant legal, reputational, and operational risks. This is not a discretionary activity—it is a statutory obligation ## Contract award
Timeline
- Completed: Award published19 June 2026Current notice
- Completed: Award date19 June 2026
- Next: Contract expiry date31 March 2027in 5 months
About the buyer
NHS England runs the NHS in England, and buys as a central healthcare organisation with its own team of procurement professionals. Much of this procurement flows through framework agreements and the Crown Commercial Service. Seven regional teams support the commissioning of healthcare services across the country. The central commercial function that develops procurement strategy for the whole NHS sits here.
Clinical services are commissioned directly or through the Provider Selection Regime.
Over the past 5 years, most of NHS England's contract awards have been in education and training, health and social work, and IT services.
Decision makers
Connect with the people behind this procurement.
| Contact name | Job title | Phone number | Work email |
|---|---|---|---|
| Head of Procurement | +44 •••• •••••• | ••••••••@nhs-england.gov | |
| Commercial Director | +44 •••• •••••• | ••••••••@nhs-england.gov | |
| Procurement Manager | +44 •••• •••••• | ••••••••@nhs-england.gov | |
| Category Lead | +44 •••• •••••• | ••••••••@nhs-england.gov | |
| Senior Buyer | +44 •••• •••••• | ••••••••@nhs-england.gov | |
| Contracts Manager | +44 •••• •••••• | ••••••••@nhs-england.gov |
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