DevOps & CI/CD for UK MedTech — MHRA Built In
ClickMasters provides DevOps & CI/CD for UK MedTech businesses with MHRA, DTAC Domain 3 compliance from Sprint 1.
Key Highlights
Compliance
+2 more standards
Pricing
DevOps & CI/CD for MedTech — UK Specifics
MHRA Software as a Medical Device (SaMD) CI/CD
MHRA regulation of Software as a Medical Device requires design controls — including change management evidence. CI/CD in SaMD development: every release must be traceable to requirements (traceability matrix), every change must have test evidence (verification), and no release without documented risk assessment update. IEC 62304 (medical device software lifecycle): CI/CD pipeline must produce IEC 62304-compliant design history file (DHF) artefacts automatically.
IEC 62304 Compliant CI/CD Pipeline
IEC 62304 software lifecycle standard for medical devices: Software of Unknown Provenance (SOUP) management (open-source library risk assessment), unit test coverage requirements (Class C software: statement coverage), and change impact assessment (every code change assessed for safety impact before merge). CI/CD pipeline artefacts as IEC 62304 evidence: unit test report (coverage metrics), static analysis report (SAST — SonarQube), SOUP vulnerability scan (Dependabot + OWASP Dependency Check), and automated regression test results.
NHS DTAC Domain 3 CI/CD Evidence Pack
DTAC Domain 3 (Technical Security) requires evidence of security controls in the development process. CI/CD produces DTAC-ready evidence automatically: GitHub Actions run log (evidence of automated security testing), OWASP ZAP DAST scan report (integrated in CI/CD), Dependabot CVE scan results, Trivy container image scan, and Cyber Essentials Plus certificate (covering cloud infrastructure). ClickMasters produces DTAC Domain 3 evidence packs as standard CI/CD output.
Regulated Change Management in MedTech CI/CD
MHRA Technical File: change management is a mandatory post-market surveillance element for medical device software. Production deployments: change record (description, risk assessment, test evidence, approval), linked to MHRA-registered version. Change approval gate: every production deployment to a MHRA-registered SaMD version requires documented approval — CI/CD enforces this via GitHub environment protection rules (named approver required before production deploy).
Compliance
MHRA
DTAC Domain 3
DCB0129
UK GDPR Art 9
Cyber Essentials Plus
NHS DSP Toolkit
Compliance & Regulations
Every solution we build for this industry is designed to meet the following regulatory and standards requirements.
MHRA
DTAC Domain 3
DCB0129
UK GDPR Art 9
Cyber Essentials Plus
NHS DSP Toolkit
Investment Options
Flexible engagement models tailored to your medtech project requirements.
£8,000–£55,000
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 CI/CD pipeline should UK MedTech companies use?
IEC 62304-compliant CI/CD pipeline: GitHub Actions (audit trail) → ESLint + TypeScript strict (static analysis) → Jest unit tests (coverage report — 80%+ for Class C software) → Playwright E2E + axe-core accessibility → OWASP ZAP DAST → Dependabot + OWASP Dependency Check (SOUP) → Docker build → Trivy container scan → staging deploy → smoke tests → production deploy (with named approver gate). ClickMasters builds this pipeline into all MedTech projects.
Does MHRA require penetration testing for medical device software?
MHRA does not specifically mandate penetration testing, but Cyber Essentials (DTAC Domain 3 minimum) and the general duty to implement appropriate cybersecurity (MHRA guidance on medical device cybersecurity, 2021) effectively require it for networked medical devices. NHS DTAC Domain 3 preferred: Cyber Essentials Plus (includes vulnerability scan). ClickMasters recommends annual CREST pen test for all MedTech SaaS deployed in NHS settings.
Ready to Build for medtech?
Let us engineer a platform that meets your industry regulations, serves your users, and scales with your ambitions.