03 · Risk Management
Risk Management: Total Lifecycle Compliance under MDR & IVDR
Under the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746, Risk Management is no longer just a milestone—it is a continuous, lifecycle-wide process. Modern regulations demand that risk management be deeply embedded into your Quality Management System (QMS) and Technical Documentation. A robust, dynamic risk system is the ultimate baseline for ensuring patient safety, preventing diagnostic or device failures, and securing a successful CE marking through Notified Body audits.
Our Core Risk Management Services
We help MedTech and Pharma build fully compliant systems according to EN ISO 14971, ensuring seamless cross-functional alignment:
Risk Analysis
Systematic identification of hazards, hazardous situations, and foreseeable misuse, with clear risk acceptability criteria.
Risk Evaluation
Once risks are estimated, risk evaluation compares them against pre-defined risk acceptability criteria established in your company’s Risk Management Plan.
Risk Control Measures
Practical, verifiable mitigation strategies that reduce risk to acceptable levels without compromising device performance.
Benefit-Risk Analysis (BRA)
Generating the objective, data-driven rationale required to prove that the clinical benefit of your device or assay decisively outweighs any residual risks.
Cross-Functional Data Integration
Linking risk files directly with your Clinical Evaluation (CER) or Performance Evaluation (PER) to systematically address specific failures, such as software glitches or false diagnostic results.
Post-Market Surveillance (PMS)
Establishing dynamic data pipelines that continuously update your risk files using real-world field data, PMCF, and PMPF inputs.
Why Partner With Us?
Isolated or static risk documentation is one of the most frequent triggers for major non-conformities during Notified Body reviews. We bridge the gap between complex regulatory text and practical engineering, delivering defensible, audit-ready documentation. Partnering with us minimizes your compliance bottlenecks, accelerates your time-to-market, and future-proofs your entire product portfolio.
Ready to make risk management continuous?
Tell us about your device or assay and your markets — we'll scope the risk file work with you.