FDA 21 CFR
Medical device regulation
ISO 13485
QMS standard
HIPAA
Data privacy law
USD 800
Starting cost
The USA's $4.5 trillion healthcare sector — the world's largest — operates under the FDA's rigorous quality management requirements for medical devices, HIPAA for health information security, and the Joint Commission for hospital quality. ISO 13485 and ISO 27001 are the two dominant ISO standards for US healthcare companies.
FDA and ISO 13485
| FDA Requirement | ISO Alignment |
|---|---|
| 21 CFR Part 820 (Quality System Regulation) | ISO 13485:2016 aligns with QSR — many requirements identical |
| 510(k) premarket notification | ISO 13485 strengthens 510(k) technical file quality evidence |
| PMA (Class III devices) | ISO 13485 required quality management documentation |
| FDA Establishment Registration | ISO 13485 supports FDA registration quality management evidence |
HIPAA and ISO 27001
HIPAA requires covered entities and business associates to implement appropriate administrative, physical, and technical safeguards for PHI (Protected Health Information). ISO 27001 provides the comprehensive information security management system that demonstrates HIPAA compliance:
- HIPAA Security Rule aligns with ISO 27001 Annex A controls
- ISO 27001 risk assessment covers HIPAA required risk analysis
- ISO 27001 incident response procedures align with HIPAA Breach Notification Rule
Cost for US Healthcare Companies
| Company Type | Standard | Cost From (USD) |
|---|---|---|
| Medical device manufacturer (Class II) | ISO 13485 | USD 2,000 |
| Healthcare IT / EHR vendor | ISO 9001 + ISO 27001 | USD 2,000 |
| Telehealth/health app company | ISO 27001 | USD 1,500 |
| Clinical lab / diagnostic | ISO 15189 or ISO 9001 | USD 1,500 |
Get ISO Certified in United States Today!
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Frequently Asked Questions
ISO 13485 and FDA 21 CFR Part 820 (QSR) have substantial alignment but are not identical. ISO 13485 certification demonstrates robust quality management to FDA inspectors but does not replace mandatory FDA registration or 510(k)/PMA submission. ISO 13485-certified companies typically perform better in FDA inspections and Form 483 audits.
ISO 27001 is not legally required by HIPAA, but it provides the strongest documented evidence of appropriate technical and organizational safeguards under 45 CFR 164.312. The HHS OCR has cited ISO 27001 in enforcement guidance as a recognized framework for HIPAA Security Rule compliance.