Medical device and life sciences documentation that satisfies FDA, EU MDR, ISO 13485, and global regulatory authorities.
Medical device documentation is among the most demanding documentation environments in any regulated industry. Every document is potentially evidence in a regulatory examination; every version transition is a controlled change event; every labeling element is a regulatory representation. The consequences of documentation failure in medical devices are not abstractions — they are product withdrawals, FDA warning letters, CE mark suspensions, and patient safety consequences.
ELDR's regulated device documentation system is built on practitioner experience at Intuitive Surgical and Philips — covering Class I, II, and III medical devices through FDA, ISO 13485, EU MDR, and GxP frameworks. The system covers the full product documentation lifecycle: from design control inputs through IFU production, technical file assembly, and post-market surveillance documentation.
FDA-compliant, ISO 13485-aligned, and EU MDR Annex I Section 23-compliant IFUs for Class I, II, and III medical devices — multi-market variants including global regulatory adaptations
Complete Technical Documentation structure aligned with EU MDR Annex II — device description, design documentation, labeling, intended purpose, and clinical evaluation summary
FDA 21 CFR Part 820.30-aligned Design History File structure and content documentation from design inputs through transfer
EU MDR-aligned Clinical Evaluation Report documenting clinical evidence for safety and performance — MEDDEV 2.7/1 Rev. 4 methodology
ISO 14971:2019-aligned risk management documentation: hazard identification, risk analysis, risk evaluation, risk control, and residual risk assessment
PMS Plan and PMS Report aligned with EU MDR Article 83-84, PSUR for Class IIb/III devices, and FDA MDR reporting framework
Corrective and Preventive Action process documentation, root cause analysis templates, and effectiveness verification records aligned with FDA 820.100
SSCP documentation for implantable and Class III devices — EU MDR Annex XV format for EUDAMED publication
ELDR Advisory and ELDR Consulting deliver documentation engagements across all six documentation systems. Request a consultation to discuss your documentation requirements.