Regulatory support, scoped around your service model.

We manage the entire CQC application – from provider and manager registration through to the registration interview and beyond. Ideal for new clinics, digital health platforms, independent hospitals and care providers entering the UK market.

Typical engagement: 2 to 4 weeks from kick-off to application submission. We work in parallel with your legal, insurance and clinical governance workstreams so registration doesn't become the bottleneck. Related: policies and procedures and common registration questions.

• Provider & manager applications
• Statement of Purpose drafting
• DBS & fit-person evidence
• Interview preparation & coaching
• Location & regulated activity scoping
• Post-registration handover pack

A dedicated workstream for telehealth providers, online prescribing platforms, virtual clinics, weight loss and GLP-1 services, aesthetics tech and digital therapeutics. Digital-first services sit at the intersection of CQC, MHRA, GPhC and data protection – we help you navigate all of it.

We help founders present their technology and clinical model in a way CQC assessors understand, translating product decisions into regulatory language. Since June 2026, online primary care providers must also submit an inclusion and exclusion criteria policy, a medical emergency policy, and indemnity that expressly covers online services – we build these into the application from the start.

• DTAC (Digital Technology Assessment Criteria)
• Clinical governance framework
• Remote consultation SOPs
• DCB0129 & DCB0160 support
• Medical device classification guidance
• Prescribing & medicines governance

An independent, inspector-style review of your service against the Single Assessment Framework. We test the evidence you'd be asked to produce, interview your leaders and staff as an assessor would, and deliver a prioritised action plan with clear timelines.

Most clients book a mock inspection six to eight weeks before they expect CQC contact – enough time to close gaps without disrupting the service.

• Single Assessment Framework review
• Leader & staff interviews
• Care record & evidence audit
• Quality statement mapping
• Prioritised action plan
• Follow-up review (optional)

Bespoke policies and procedures drafted to your actual model of care – not generic templates renamed with your logo. We work with your clinical and operational leads to document how your service really runs, and keep it updated as you grow.

Every document is version-controlled, mapped to the relevant CQC quality statements, and formatted so staff can actually read and use them. Our standard submission set covers the core policies CQC expects to see at registration, including safeguarding, consent and mental capacity, prescribing and medicines management, clinical governance and audit, information governance, and business continuity.

• Service-specific drafting
• Annual review cycles
• Version-controlled library
• Staff-friendly formatting
• Mapped to quality statements
• Training pack alignment

A monthly retainer for providers who want a regulatory partner on call. We embed with your senior team, join your governance meetings, handle notifications, and keep your compliance evidence pack assessment-ready year-round.

Typical clients: growing multi-site clinics, digital health scale-ups, and care providers without an in-house compliance lead.

• Monthly compliance reviews
• Statutory notification support
• Governance meeting attendance
• Clinical audit & QI programme
• Policy maintenance
• Priority phone & email access

Rapid-response support for providers facing warning notices, a Notice of Proposal to refuse registration, conditions on registration, or services placed in special measures. We work discreetly and fast – embedding senior consultants where necessary to stabilise the service and build a credible improvement plan.

We also run a dedicated rescue and resubmission service for applications CQC has returned as invalid or refused: we obtain the failed submission, identify what triggered the return, rework it, and carry it through to acceptance and the registered manager interview. Notices of Proposal carry a strict statutory deadline for representations, so contact us the day you receive one.

• Warning notice response
• Notice of Proposal representations
• Rescue & resubmission of refused applications
• Improvement & action plans
• Board & investor reporting
• Re-inspection readiness

NHS clinical risk management under the information standards DCB0129, for manufacturers of health IT, and DCB0160, for the organisations deploying it. We produce the full documentation set – Clinical Risk Management Plan, Hazard Log and Clinical Safety Case Report – and complete the clinical safety section of DTAC.

We also act as a fractional Clinical Safety Officer. The CSO must be a registered clinician trained in clinical risk management and cannot be a non-clinical quality manager, which is the single most common reason a digital health company cannot produce a valid safety case. Clinical safety and fractional CSO support →

• DCB0129 for manufacturers
• DCB0160 for deploying organisations
• Fractional Clinical Safety Officer
• Clinical Risk Management Plan
• Hazard Log & safety case report
• DTAC clinical safety evidence

Support for medical laboratories seeking or maintaining UKAS accreditation to ISO 15189:2022 – the standard covering both the quality management system and the technical competence of the laboratory, across the whole examination pathway.

Laboratory services in England usually need CQC registration for diagnostic and screening procedures alongside accreditation. The governance, document control, competency and audit evidence overlaps substantially, so we run both as one programme. UKAS ISO 15189 support →

• Gap analysis against ISO 15189:2022
• Quality management system build
• Validation & verification files
• Competency assessment records
• Mock assessment & UKAS preparation
• Aligned CQC registration

Two questions decide everything downstream: is your product a medical device, and if so what class? We produce a written, reasoned qualification and classification opinion under the UK Medical Devices Regulations 2002 and EU MDR 2017/745, with the rules applied explicitly rather than asserted.

Rule 11 pulls a great deal of clinical software above Class I, which is where digital health founders most often discover they need a Notified Body they had not budgeted for. We also join device regulation to the CQC and NHS clinical safety obligations that usually sit alongside it. Medical device regulation →

• Qualification & classification opinion
• Software & AI as a medical device
• EU MDR Rule 11 analysis
• UKCA & CE market access routes
• ISO 13485 & ISO 14971 readiness
• UK Responsible Person arrangements