Clinical Safety Officer (DCB0129 / DCB0160) as a Service
Your named Clinical Safety Officer under DCB0129/0160, held by a registered clinician.
Retained work: an ongoing operational role. It cannot be combined with independent assurance for the same client.
Delivered by: Registered Pharmacist (GPhC); DCB0129 / DCB0160-trained Clinical Safety Officer
Scope
We act as your named Clinical Safety Officer under DCB0129 (for manufacturers) and DCB0160 (for health and care organisations). This is the clinical safety oversight that NHS contracts and DTAC require, for healthtech vendors and care providers who do not have a qualified clinician to hold the role. Available per product or as an ongoing monthly retainer.
What you get
- A named Clinical Safety Officer, held by a registered clinician
- Clinical risk management file: hazard log and Clinical Safety Case Report
- Clinical risk management aligned to DCB0129 and DCB0160 and to NHS expectations
- Clinical safety input across the product lifecycle, not just a one-off sign-off
Deliverables
A Clinical Safety Case Report and Hazard Log signed by a registered clinician, ready for NHS procurement, DTAC, and supplier onboarding
Price
from £4,000
Setup from £4,000 per product. Retainers: £500/month single product, £1,200/month portfolio.
All prices exclude VAT.
Frameworks referenced
Not sure if this is the right engagement?
Book a free scoping call. We will point you to the right next step, whether that is this service, our paid diagnostic, or something else.