Risk Management & Biocompatibility Services

Risk Management & Biocompatibility Services

SARACA provides specialized Risk Management and Biocompatibility documentation consulting services for Medical Devices and In Vitro Diagnostics (IVDs) across the entire product lifecycle. Our services align with ISO 14971, ISO 24971, ISO 10993 series, EU MDR (2017/745), EU IVDR (2017/746), and US FDA expectations, supporting regulatory submissions and ongoing compliance through robust, regulator-ready documentation.

Medical Device – Documentation & Consulting Services:
- Risk Management Plan (RMP) and Risk Management Report (RMR) preparation
- Hazard identification and Hazard Analysis
- Risk Analysis, Risk Evaluation, and Risk Acceptability justification
- Risk–Benefit Analysis and overall residual risk justification
- FMEA documentation (DFMEA, PFMEA, SFMEA)
- Risk Management File (RMF) creation
- Risk Management File updates based on design changes, PMS, PMCF, complaints, and vigilance data
- Alignment of risk documentation with CER, PMS, PMCF, and SSCP

IVD – Documentation & Consulting Services:
- Risk Management planning and reporting per ISO 14971 and ISO 24971
- Hazard identification related to incorrect results, usability, and software risks
- Risk Analysis and Risk Evaluation aligned with intended purpose and clinical performance
- Risk control documentation linked to design, IFU, labeling, and software
- Risk–Benefit Analysis supporting IVDR Technical Documentation
- FMEA documentation for reagents, processes, and systems
- Risk Management File (RMF) creation
- Risk Management File updates based on design changes, PMS, PMPF, complaints, and vigilance data