Why Should NHS Trusts Choose Yoctobe for SaMD Development
Liverpool-based SaMD development. AWS Partner. DTAC ready. Regulatory flow up to 20x cheaper than traditional vendors.
The Cost Reality
Traditional NHS SaMD vendors: £50K-£200K for regulatory documentation alone. Yoctobe: Fixed monthly regulatory platform cost. Everything included.
What you get:
- Complete ISO 13485 Quality Management System
- All IEC 62304 software documentation templates
- ISO 14971 risk management frameworks
- IEC 62366 usability engineering templates
- FDA 21 CFR Part 11 compliant e-signatures
- Unlimited users, unlimited documents
- We handle all the regulatory admin
Real project cost comparison:
- Traditional vendor: £280K-£450K total
- Yoctobe: £95K-£125K total
- You save: £185K-£325K per project
Risk Management: Systematic Approach
Regulatory Framework: Our regulatory partners have guided 150+ SaMD projects through successful MHRA approvals. Their proven documentation templates are built into our development process.
NHS Digital Compliance: We meet NHS Digital standards for:
- Data Security and Protection Toolkit requirements
- Technical assurance processes
- Information Governance frameworks
- FHIR R4 integration standards
AWS Partnership Benefits:
- UK-based infrastructure only
- ISO 27001 certified hosting environment
- Automated backup and disaster recovery
- 24/7 monitoring and incident response
Delivery: Structured Implementation Process
Our Development Process:
- Week 1-2: NHS Information Governance submission
- Week 3-6: Development with clinical user feedback
- Week 7-8: NHS Digital technical assurance preparation
- Week 9-12: Deployment and go-live support
Quality Standards:
- ISO 13485 development processes
- Automated testing against NHS APIs
- Clinical safety documentation throughout development
- AWS security standards compliance
Budget Transparency: No Hidden Costs
Development Pricing:
- Standard NHS FHIR integration: £35K-£45K fixed
- Complex legacy system integration: £55K-£75K fixed
- Regulatory platform access: Fixed monthly cost
- NHS Digital technical assurance: £8K fixed fee
Operational Costs:
- AWS infrastructure: Cost + 10% management fee
- Support and maintenance: £2K/month standard, £3.5K/month 24×7
- Compliance updates: Included in platform cost
Payment Structure:
- 30% on NHS Information Governance approval
- 40% on development completion
- 30% on successful deployment + 30-day stability
Cost Protection: Fixed-price contracts with change control process for scope modifications.
Long-Term Partnership: Sustainable Vendor Relationship
Relationship Management:
- Dedicated technical account manager
- Annual contract reviews with transparent pricing
- Proactive NHS policy change notifications
- Strategic planning aligned with Trust digital objectives
Knowledge Transfer:
- Complete technical documentation handover
- Staff training for clinical and IT teams
- Source code access and documentation
- Migration support if vendor relationship ends
Vendor Independence:
- Open standards implementation (FHIR R4, SNOMED CT)
- No proprietary technology lock-in
- Data export capabilities built into every system
- AWS-agnostic architecture where possible
Why We’re Competitive
Traditional vendors: Learn NHS requirements on your project budget. Charge consultancy rates for regulatory expertise.
Yoctobe: Regulatory compliance systematized through proven templates and processes. Fixed costs, proven outcomes.
Traditional vendors: Custom solutions requiring extensive NHS-specific modifications.
Yoctobe: NHS-first development approach. Built for NHS workflows from ground up.
Traditional vendors: Regulatory compliance as expensive add-on service.
Yoctobe: Compliance built into development process. Same systematic approach for every project.
What We Actually Deliver
Concrete Outcomes:
- SaMD software that passes NHS Digital technical assurance
- MHRA-ready documentation that meets DTAC requirements
- Software that integrates with existing NHS systems
- Fixed-price certainty in volatile procurement environment
What We Don’t Promise:
- Unrealistic delivery timelines
- Clinical expertise outside software development
- Offshore development for NHS data
- Generic healthcare solutions adapted for NHS
