Compliance Built for
the Stakes of
Healthcare.
Healthcare organizations face the most consequential compliance environment of any sector. Patient safety, special category data, clinical continuity — and the regulators, procurement teams, and enterprise clients who demand proof of all of it. Complify unifies every obligation into one auditable program.
Built for every segment
of healthcare.
From NHS trusts managing patient data at scale to medical device startups navigating MDR — Complify adapts to the specific regulatory profile of your healthcare segment.
Manage patient data security, clinical continuity, and regulatory compliance across complex multi-site environments. Meet NHS DSP Toolkit, ISO 27001, and GDPR requirements simultaneously.
Protect clinical trial data, research IP, and manufacturing systems. ISO 27001 and ISO 9001 are increasingly required by enterprise pharma partners and regulatory bodies.
ISO 13485 and MDR/IVDR compliance alongside information security and quality management. Complify maps ISO 9001 controls directly to ISO 13485 requirements.
Fast-growing healthtechs need enterprise-grade compliance from day one. NHS Digital Assessment, ISO 27001, GDPR, and SOC 2 for NHS procurement and enterprise sales.
Every regulation your
compliance team manages.
Healthcare compliance spans information security, quality management, privacy, and clinical continuity — across frameworks that share significant structural overlap. Complify maps all of it from a single platform.
Protect patient data, clinical systems, and research assets. Required by NHS DSP Toolkit, HIPAA business associates, and enterprise healthcare procurement.
CriticalHealth data is special category under GDPR. Article 9 processing requires explicit consent or specific legal basis, with enhanced accountability obligations.
CriticalProcess consistency, nonconformity management, and continual improvement — foundation for regulatory compliance in pharmaceutical and medical device environments.
CriticalQuality management system for medical device manufacturers. Required for CE marking and FDA 21 CFR Part 820 alignment. Maps closely to ISO 9001.
HighPost-market surveillance, clinical evaluation, UDI implementation, and technical documentation for CE-marked medical devices and IVDs.
HighHealthcare organizations cannot afford downtime. ISO 22301 provides the structured framework for clinical continuity, disaster recovery, and operational resilience.
HighStructured GDPR accountability for patient data processing. Maps directly to GDPR Article 5, 9, 25, and 30 obligations for health data controllers.
HighHospitals and healthcare providers above threshold size are essential entities under NIS2, with incident reporting and security measure obligations.
MediumOne platform.
Every healthcare obligation.
Complify's unified control library means controls shared across ISO 27001, GDPR, ISO 9001, and ISO 22301 are mapped once — eliminating duplicated work across your compliance team.
ISO 27001 is the foundation of NHS DTAC, HIPAA alignment, and enterprise healthcare procurement. Build it once and reuse controls across every other framework.
Health data requires Article 9 processing conditions, DPIAs for high-risk processing, and a DPO in most healthcare contexts. Complify operationalizes all of it.
ISO 9001 shares 80%+ control overlap with ISO 13485. Complify runs both from a single platform — with ISO 13485-specific additions for medical device manufacturers.
Clinical system downtime has direct patient safety implications. Complify BCMS structures your continuity planning around clinical criticality — with RTO/RPO targets per system.
ISO 27701 certification demonstrates structured accountability for patient data processing. Annex D maps directly to GDPR obligations — the strongest accountability signal available.
The compliance challenges
healthcare teams face daily.
We built Complify by talking to compliance officers, CISOs, DPOs, and quality managers at healthcare organizations. These are the problems they told us keep them up at night.
Health data carries the highest risk classification under GDPR. Complify automates the additional documentation, consent management, and breach notification requirements for Article 9 data.
ISO 13485 + ISO 9001 + ISO 27001 share enormous structural overlap. Complify maps shared controls automatically — one audit pack serves multiple frameworks.
Clinical systems, cloud providers, and software vendors all need security assessment. Complify tracks supplier risk, contract requirements, and due diligence evidence in one place.
MDR transition deadlines, NIS2, EU AI Act implications for clinical AI — the regulatory pipeline is accelerating. Complify maps new obligations to your existing control library automatically.
NHS Digital Assessment Criteria (DTAC) and DSP Toolkit require structured evidence of information governance. Complify generates these artefacts directly from your ISO 27001 program.
Ransomware and system failures in healthcare have direct patient safety implications. Complify BCMS structures your clinical continuity planning and validates it through regular exercises.
A structured path through
healthcare compliance.
Healthcare compliance does not have to be tackled all at once. Complify structures a sequenced approach — building each framework on the foundation of the last, maximising reuse and minimising total effort.
Complify maps your specific regulatory obligations based on your segment — hospital, pharma, medtech, or healthtech. You see exactly which frameworks apply and in what order to tackle them.
ISO 27001 is the fastest path to unblocking NHS procurement, enterprise sales, and GDPR Article 32 compliance simultaneously. Complify ISMS guides you from gap to certification.
Add structured GDPR compliance and ISO 27701 certification on top of your ISMS foundation. Shared controls mean 60% less work — and a certifiable accountability posture for health data.
Layer ISO 9001, ISO 13485, and ISO 22301 depending on your segment. Complify maps shared infrastructure from your existing ISMS — dramatically reducing total certification effort.
Annual surveillance audits, NHS re-assessments, and regulatory inspections become routine rather than panic-inducing. Complify keeps your evidence current and your program continuously audit-ready.
Healthcare teams
that chose Complify.
"We needed NHS DTAC, ISO 27001, and GDPR compliance to get on the procurement framework. Complify mapped all three simultaneously — we achieved ISO 27001 certification in five months and passed our DTAC assessment first time."
"We were running ISO 9001 and ISO 13485 in parallel spreadsheets. Complify unified both programs — the shared control structure meant we cut our audit preparation time in half."
See how Complify handles healthcare compliance.
Our healthcare specialists will walk you through a tailored demo — mapped to your specific regulatory obligations, segment, and compliance maturity.