Estimated Value
Up to £75,000
Deadline
Not specified
Published
19 June 2026
Type
Not specified
Overview
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
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Award Details
SCARLET GLOBAL HOLDINGS LTD
£75,000
Likely incumbents
Suppliers who won similar work from this buyer in the last 5 years.
- 1
Accord UK Ltd
8 contracts wonlatest 27 Aug 2026ends 31 Jan 2029£2bn
total awarded
- 2
Sheffield Teaching Hospitals NHS Foundation Trust
7 contracts wonlatest 22 Sept 2026£780m
total awarded
- 3
The Newcastle upon Tyne Hospitals NHS Foundation Trust
7 contracts wonlatest 22 Sept 2026£794m
total awarded
- 4
MILPHARM LIMITED
7 contracts wonlatest 27 Aug 2026ends 31 May 2030£1bn
total awarded
- 5
TEVA UK LIMITED
7 contracts wonlatest 27 Aug 2026ends 31 May 2030£2bn
total awarded
Accord UK Ltd is the most likely incumbent based on recency and category match. To win, bidders typically need a clearly differentiated proposition or a price advantage.
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two years of filed accountsyour financial standingturnover vs contract valueyour Companies House recordcash flow for 30-day termscredit scores and ratios
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Buyer Profile
NHS EnglandKey Dates
Published
19 June 2026
Submission deadline
Not specified
Notice type
award
Source
find a tender
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