Cloud-Native Development for UK MedTech — MHRA Built In
ClickMasters provides Cloud-Native Development for UK MedTech businesses with MHRA, IEC 62304 compliance from Sprint 1.
Key Highlights
Compliance
+4 more standards
Pricing
Cloud-Native Development for MedTech — UK Specifics
NHSE Cloud Security Standards for Clinical Software
NHS England Cloud Security Standards: NHS clinical software deployed on cloud must satisfy NHS Cloud Security Standards (aligned with NCSC 14 Principles). Key standards: (1) data at rest encryption (AES-256 — AWS S3 server-side encryption, RDS encryption), (2) data in transit encryption (TLS 1.2+ — AWS ALB enforces, HTTP redirected to HTTPS), (3) UK data residency (eu-west-2 — not cross-border without NHS IG approval), (4) access control (IAM roles, MFA for all clinical staff, NHS SDS for clinical authentication), (5) audit logging (CloudWatch — 7 years retention for NHS DSP Toolkit). ClickMasters configures all 5 as standard on NHS cloud-native builds.
AWS NHS Landing Zone Architecture
NHS Landing Zone (NLZ): NHS-specific AWS architecture for clinical workloads. NLZ components: (1) NHS Trust AWS account structure (Organizational Units — Production, Non-Production, Sandbox), (2) Service Control Policies (SCPs — prevent resources being created outside eu-west-2), (3) CloudTrail (immutable audit log of all AWS API calls — required for NHS DSP Toolkit), (4) Security Hub (NHS DTAC security benchmarks — CIS Level 2), (5) Config (compliance rules — S3 public access blocked, CloudTrail enabled, MFA on root). ClickMasters configures NLZ-compatible architecture — even when client does not have formal NLZ, the security controls match.
NHS FHIR Bulk Data Access for MedTech Analytics
FHIR Bulk Data Access ($export): enables large-scale extraction of FHIR R4 resources for analytics and machine learning. FHIR Bulk export: GET /Patient/$export (all patient records), GET /Group/{groupId}/$export (specific patient cohort). NDJSON output: each resource type exported as newline-delimited JSON files to S3. Analytics pipeline: S3 NDJSON → AWS Glue (ETL — FHIR R4 to analytics schema) → Athena (SQL queries for analytics) → QuickSight (clinical dashboards). UK GDPR Article 9: bulk patient data export — legal basis (Article 9(2)(j) — scientific research, with appropriate safeguards including pseudonymisation and data access committee approval).
NHS Digital Health Technology Catalogue
NHS DHSC Digital Health Technology Catalogue (DHTC): replaces NHS App Library. MedTech products listed on DHTC must: (1) pass DTAC assessment, (2) provide CE/UKCA marking evidence (if medical device), (3) provide peer-reviewed clinical evidence (if clinical effectiveness claims made), (4) comply with NHS Information Standards. DHTC listing: enables NHS trusts to procure listed products under national framework. ClickMasters produces DHTC application pack for MedTech SaaS clients — DTAC evidence, regulatory certificates, and clinical evidence summary.
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.
£30,000–£160,000
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 AWS architecture does NHS DTAC require for clinical cloud-native software?
NHS DTAC Domain 2 (Data Protection) cloud-native requirements: (1) AWS eu-west-2 (UK data residency — confirmed in DPA), (2) encryption at rest and in transit (AES-256 S3, RDS — standard AWS defaults), (3) access control (IAM least privilege, MFA mandatory, no long-lived credentials), (4) audit logging (CloudTrail — all AWS API calls logged, 7-year retention), (5) vulnerability management (Dependabot + Trivy + Amazon Inspector — patching within 14 days of critical CVE). ClickMasters configures all 5 as standard on every NHS clinical cloud-native build — DTAC Domain 2 evidence pack generated from AWS Config compliance reports.
How does NHS cloud-native architecture differ from standard cloud-native?
NHS cloud-native vs standard cloud-native: (1) Data residency: NHS requires eu-west-2 explicitly — cannot use eu-west-1 (Ireland) without NHS IG approval. (2) Authentication: NHS SDS (Smartcard RBAC) or NHS Login (patient-facing) required — cannot use standard Cognito/Clerk without NHS-specific configuration. (3) Audit logging: 7-year retention required — standard CloudWatch default is 30 days. (4) FHIR R4: NHS systems communicate via FHIR R4 — NHS cloud-native must include HAPI FHIR server or FHIR Facade. (5) DTAC evidence: every sprint produces DTAC evidence artefacts (test reports, security scan results) — not standard practice outside NHS. ClickMasters builds all 5 differences as standard on NHS cloud-native projects.
Ready to Build for medtech?
Let us engineer a platform that meets your industry regulations, serves your users, and scales with your ambitions.