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FDA · ISO 13485 · HIPAA · EU MDR

Healthcare

Healthcare documentation and regulatory compliance resources across FDA 21 CFR, ISO 13485, HIPAA, and EU MDR frameworks.

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About This Sector

Healthcare and medical technology institutions face some of the most demanding documentation and regulatory requirements in any sector. FDA audit readiness, EU MDR technical file requirements, HIPAA administrative safeguards, and ISO 13485-compliant quality management documentation all demand structured, traceable, defensible documentation systems. ELDR Institute resources in this domain are developed with the specificity of regulated healthcare environments.

Primary Standards

FDA
ISO 13485
HIPAA
EU MDR

Institute Resources

Primary resources
for healthcare practitioners.

FDA 21 CFR Part 820 Design Controls

Design history files, design input/output documentation, and design verification and validation documentation for FDA-regulated medical devices.

EU MDR Technical Files

Technical file structure and content requirements under EU MDR 2017/745, including clinical evaluation, risk management, and labeling documentation.

ISO 13485 Quality Management

Quality management system documentation for medical device manufacturers — procedures, records, and audit-ready quality system documentation.

HIPAA Administrative Safeguards

HIPAA Security Rule documentation covering administrative, physical, and technical safeguard policies and procedures for covered entities and business associates.

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ELDR Advisory

Documentation that holds up
under examination.

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