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ISO Certification for MedTech & Healthcare

BALTUM supports hospitals, MedTech companies, digital health platforms, and health data processors in achieving internationally recognised certifications that satisfy regulatory requirements, NHS and health system procurement, and patient data governance obligations.

ISO 27001HITRUSTGDPRISO 42001ISO 9001

Why Certification Matters in Healthcare

Healthcare organisations operate under the most stringent data protection and quality requirements of any sector. Patient data breaches carry significant regulatory, reputational, and clinical consequences. ISO 27001, HITRUST, and GDPR compliance have become baseline requirements for health data processors, NHS suppliers, and US healthcare vendors alike.

Relevant Certifications for Healthcare

  • ISO/IEC 27001 — Information security management; required by NHS Digital, health system procurement, and medical device market access.
  • ISO/IEC 42001 — AI Management System; critical for diagnostic AI, clinical decision support, and FDA/CE AI device governance.
  • HITRUST CSF — Mandatory for US health system vendors handling PHI; harmonises HIPAA, NIST, and ISO controls.
  • ISO 9001 — Quality Management; required for medical device regulatory submission in many jurisdictions.
  • GDPR / UK GDPR — Privacy compliance for EU and UK health data processing under Article 9 special category rules.

AI in Healthcare — ISO 42001 and the EU AI Act

AI systems used in healthcare — including diagnostic imaging AI, clinical decision support, and predictive analytics — are classified as high-risk under the EU AI Act. ISO 42001 certification provides the governance framework required for AI Act compliance, including risk assessments, transparency obligations, and human oversight mechanisms. BALTUM's integrated ISO 27001 + ISO 42001 programme is specifically designed for MedTech organisations deploying AI-enabled products.

NHS Supplier Requirements

NHS Digital's Data Security and Protection Toolkit (DSPT) requires NHS suppliers to demonstrate compliance with the National Data Guardian's 10 Data Security Standards. ISO 27001 certification provides strong alignment with DSPT requirements and is widely accepted as evidence of compliance by NHS procurement teams.

Typical Engagement

  • ISO 27001 for a MedTech scale-up: 3–5 months
  • ISO 27001 + ISO 42001 integrated: 4–6 months
  • HITRUST i1 readiness + assessment: 4–6 months