API Development for UK MedTech — MHRA Built In
ClickMasters provides API Development for UK MedTech businesses with MHRA, IEC 62304 compliance from Sprint 1.
Key Highlights
Compliance
+3 more standards
Pricing
API Development for MedTech — UK Specifics
NHS SMART on FHIR Application API
SMART on FHIR (Substitutable Medical Applications, Reusable Technologies): open standard for launching clinical apps from within EHR systems. SMART app launch: (1) clinical user opens SMART-enabled EHR (Epic, Cerner, System One — all support SMART on FHIR), (2) launches ClickMasters MedTech SMART app (iframe within EHR), (3) SMART app receives patient context (NHS number, encounter ID) via FHIR R4 launch context, (4) SMART app queries FHIR server for relevant clinical data (SMART app makes FHIR API calls with OAuth 2.0 token), (5) clinical decision support displayed in EHR context. NHS benefits: no separate login for MedTech app (uses NHS SDS credentials from EHR), patient context automatically available.
Wearable Device API Integration for MedTech
Wearable and remote monitoring device APIs: (1) Apple HealthKit API (iOS — heart rate, activity, blood glucose from Apple Watch and connected devices), (2) Google Fit API (Android — activity, heart rate, sleep), (3) NHS-approved remote monitoring devices (Bluetooth LE — custom SDK or react-native-ble-plx), (4) Fitbit API (heart rate, sleep quality, activity level — OAuth 2.0, 150 API calls/hour rate limit). UK GDPR Article 9: wearable health data is special category — explicit consent required for processing, purpose limitation strictly enforced. DTAC Domain 2: wearable data processing requires NHS DTAC data protection assessment — ClickMasters includes wearable device data flows in all DTAC Domain 1 data flow diagrams.
NHS Spine and GP Connect API Integration
NHS Spine: NHS national infrastructure for clinical data exchange. GP Connect API: access GP records from any NHS system. GP Connect access record (structured): medications (FHIR MedicationStatement), allergies (FHIR AllergyIntolerance), conditions (FHIR Condition), appointments (FHIR Appointment). GP Connect send document: MedTech app can write clinical documents back to GP record (FHIR DocumentReference). NHS Spine integration: Personal Demographics Service (PDS) for NHS number lookup, Organisational Data Service (ODS) for NHS organisation codes, Spine Directory Service (SDS) for staff authentication (RBAC). ClickMasters has completed GP Connect integration for 6 NHS MedTech clients — integration patterns well-understood.
Medical Device API Regulatory Context
MHRA post-market surveillance APIs: IEC 62304 requires post-market surveillance — APIs for real-world performance monitoring. Incident reporting: MHRA Yellow Card API (adverse event reporting for medical devices — mandatory for Class IIa+ devices). Vigilance API: EU EUDAMED API (European database for medical devices — post-Brexit, UK devices reported to MHRA). Device registration: MHRA device registration API (DESH — Device Equipment and Software Hub — required for UK marketed medical devices). ClickMasters MedTech API integration: all 4 MHRA regulatory APIs implemented as standard for Class IIa+ medical device software.
Compliance
MHRA
IEC 62304
DCB0129
DTAC
NHS DSP Toolkit
UK GDPR Article 9
Cyber Essentials Plus
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
Investment Options
Flexible engagement models tailored to your medtech project requirements.
£10,000–£50,000
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 NHS APIs does MedTech software need to integrate?
Core NHS MedTech API integrations: (1) PDS FHIR R4 (patient demographics — NHS number lookup and demographics), (2) GP Connect (GP record access — medications, allergies, conditions), (3) NHS SDS / NHS Login (staff and patient authentication), (4) eRS FHIR R4 (electronic referrals — create, view, manage referrals), (5) NHS FHIR Bulk Data (population analytics — $export for large-scale data access). Secondary: SMSP (Spine Mini Service Provider — for simpler FHIR queries), NRL (National Record Locator — find patient records across NHS systems), Pathology Results API (ARDS — laboratory results). ClickMasters has integrated all 7 NHS APIs across our MedTech portfolio — ready-made integration modules for each.
How long does NHS FHIR R4 API integration take?
NHS FHIR R4 API integration timelines: (1) PDS (patient demographics — simplest): 2–3 weeks including NHS sandbox testing. (2) GP Connect (structured record access): 6–10 weeks including GPSoC clinical assurance and NHS Digital onboarding. (3) NHS Login: 3–4 weeks for patient-facing apps, 4–6 weeks for NHS App integration. (4) eRS (referral management): 4–8 weeks including NHS Digital onboarding. (5) FHIR Bulk Data ($export): 4–6 weeks. Each NHS API requires NHS Digital API onboarding (separate process per API — allow 2–4 additional weeks for approval). ClickMasters maintains established relationships with NHS Digital API onboarding team — reduces approval time.
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Let us engineer a platform that meets your industry regulations, serves your users, and scales with your ambitions.