SaaS Development for UK MedTech — MHRA Built In
ClickMasters provides SaaS Development for UK MedTech businesses with MHRA, IEC 62304 compliance from Sprint 1.
Key Highlights
Compliance
+4 more standards
Pricing
SaaS Development for MedTech — UK Specifics
NHS Shared Care Record (ShCR) Integration
NHS Shared Care Records: all NHS integrated care systems are implementing Shared Care Records (ShCR) — single patient record shared across GP, hospital, community, and mental health services. ShCR FHIR R4 API: ClickMasters integrates MedTech SaaS with regional ShCR platforms (Orion Health, Graphnet, ICS Digital) via FHIR R4. ShCR query: patient demographic query (NHS Number via PDS), summary record (conditions, medications, allergies, recent encounters), and write-back (new encounters added to ShCR after clinical interaction). DTAC Domain 4 (Interoperability): ShCR integration is increasingly a DTAC pre-requisite for patient-facing clinical software.
NHS App Integration for Patient-Facing MedTech
NHS App (8M+ registered users): patient-facing MedTech SaaS can integrate directly with the NHS App. NHS App features: health record (View your GP record), services (book appointments, order prescriptions), and third-party app integration (NHS App API — third-party apps displayed within NHS App). NHS App onboarding: NHS App store application (NHS England Digital review), NHS Login integration (OIDC — NHS App handles patient identity), and NHS App API (embed MedTech SaaS features within NHS App shell). ClickMasters has achieved NHS App store listings for HealthTech clients — the review process takes 6–12 weeks.
NHSX AI Award and NHS AI Lab Integration
NHS AI Lab (NHSX): NHS-funded AI innovation programme. NHS AI in Health and Care Award: competitive funding for AI-enabled MedTech (£1M+ awards). ClickMasters supports AI MedTech clients through: (1) MHRA SaMD AI classification (Class I, IIa, IIb depending on AI intended purpose), (2) DCB0129 AI hazard assessment (AI-specific hazards: false positive, false negative, bias — demographic parity testing), (3) NHS AI Lab Evidence Standards Framework (14 standards — model transparency, bias testing, deployment safety). ClickMasters has supported 3 successful NHS AI Lab award applications.
Multi-Trust SaaS Contracting for NHS Enterprise Sales
NHS Enterprise SaaS: selling to multiple NHS Trusts requires navigating NHS procurement frameworks. G-Cloud: ClickMasters MedTech SaaS clients listed on G-Cloud — NHS Trusts can procure directly. NHS SBS (Shared Business Services) — framework contract. Procurement complexity: each NHS Trust may require separate DTAC assessment (or platform-level DTAC), separate Data Processing Agreement (Article 28 DPA), and separate NHS Information Governance review. ClickMasters produces a Trust Onboarding Pack (DPA template, DTAC evidence pack, IG review responses) — reduces each Trust onboarding from 12 weeks to 4–6 weeks.
Compliance
MHRA
IEC 62304
DCB0129
DTAC
NHS DSP Toolkit
UK GDPR Article 9
Cyber Essentials Plus
ISO 27001
Compliance & Regulations
Every solution we build for this industry is designed to meet the following regulatory and standards requirements.
MHRA
IEC 62304
DCB0129
DTAC
NHS DSP Toolkit
UK GDPR Article 9
Cyber Essentials Plus
ISO 27001
Investment Options
Flexible engagement models tailored to your medtech project requirements.
£45,000–£200,000
Full engagement
- Industry-specific approach
- UK GDPR compliant
- Dedicated technical lead
£3,500–£8,000
Scoping
- Industry-specific approach
- UK GDPR compliant
- Dedicated technical lead
from £2,000/mo
Ongoing support
- Industry-specific approach
- UK GDPR compliant
- Dedicated technical lead
What Our Clients Say
Success stories from clients in medtech industry.
“ClickMasters transformed our digital infrastructure. Their understanding of UK fintech regulations saved us months of compliance work.”
Sarah Mitchell
CTO, FinTech Solutions Ltd
“The team's expertise in NHS integrations and DTAC compliance was invaluable. They delivered on time and within budget.”
Dr. James Cooper
Medical Director, HealthFirst UK
“Their grasp of FCA requirements and insurance sector nuances helped us launch our platform 40% faster than expected.”
Michael Brooks
CEO, InsureTech Pro
Frequently Asked Questions
Common questions about medtech software development.
What is the fastest route to NHS Enterprise SaaS procurement?
Fastest NHS Enterprise SaaS procurement route: (1) G-Cloud listing (£0 cost, 4 weeks — enables direct award up to £616,575 without competitive tender). (2) Platform-level DTAC (covers all NHS Trust deployments — 8–16 weeks including build + assessment). (3) Trust Onboarding Pack (DPA template, IG response templates, technical documentation — reduces per-Trust onboarding from 12 weeks to 4–6 weeks). (4) Reference Trust (first Trust deployment as a reference — subsequent Trusts adopt faster with reference evidence). ClickMasters manages G-Cloud listing and DTAC for MedTech SaaS clients as part of go-to-market support.
What does NHS App store listing require for MedTech SaaS?
NHS App store listing requirements: (1) NHS Login integration (OIDC — patient authentication via NHS number and date of birth verification), (2) NHS App API compliance (UI/UX meets NHS Design System standards), (3) clinical safety (DCB0129 Clinical Safety Officer sign-off), (4) NHS England Digital review (privacy, security, clinical safety, evidence review — 6–12 weeks), (5) technical review (penetration test, accessibility WCAG 2.1 AA). ClickMasters has achieved NHS App store listing for HealthTech clients in as few as 14 weeks total — starting from Technical Discovery.
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Let us engineer a platform that meets your industry regulations, serves your users, and scales with your ambitions.