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I will prepare iso 14971 medical device risk management documentation
Proven Festus
Over deze dienst
Inadequate risk documentation is one of the most common reasons medical devices fail FDA 510(k) reviews and ISO 13485 audits. Regulators demand a continuous, systematic risk evaluation process that proves your product is safe across its entire lifecycle under ISO 14971:2019.
I develop compliant, audit-ready Risk Management Files (RMF) that satisfy both the US FDA (21 CFR 820 / QMSR) and international notified bodies.
What Your Risk Documentation Includes:
- Risk Management Plan (RMP) detailing risk acceptability criteria
- Preliminary Hazard Analysis (PHA) & Hazard Identification
- Failure Mode and Effects Analysis (dFMEA / uFMEA / pFMEA)
- Risk Mitigation & Control Verification Matrix
- Residual Risk Evaluation & Risk-Benefit Analysis (RBA)
- Final Risk Management Report (RMR) ready for your DHF and 510(k)
From mechanical implants and wearable sensors to complex diagnostic systems and AI medical algorithms, I structure your risk architecture to demonstrate clear safety profiles without over-complicating engineering workflows.
Build an audit-proof Risk Management File. Select your package or message me today to get started.
Maak kennis met Proven Festus
Proven Festus
FDA Regulatory Affairs Specialist, Medical Device Quality, 510k Expert
- Afkomstig uitNigeria
- Lid sindsaug 2026
- Gem. reactietijd1 uur
Talen
Engels, Nederlands
I am Proven Festus, an FDA Regulatory Affairs & Quality Assurance Specialist helping MedTech innovators, hardware startups, and manufacturers achieve FDA 510(k) clearance and global compliance. Specializing in 21 CFR 820, ISO 14971, eSTAR dossiers, and labeling, I de-risk Class I, II, and SaMD technologies. I build audit-proof submissions that eliminate Refuse-to-Accept (RTA) holds and slash review cycles. Fast, defensible, and investor-ready. Message me with your device details to secure your US market clearance strategy today.
Veelgestelde vragen
Which version of the standard do you follow?
All documentation is generated strictly according to ISO 14971:2019 and the European harmonized standard EN ISO 14971:2019+A11:2021.
What is the difference between a PHA and a dFMEA?
A Preliminary Hazard Analysis (PHA) identifies high-level hazards early in design, while a Design Failure Mode and Effects Analysis (dFMEA) investigates specific component-level failure modes, causes, and controls.
Does this satisfy FDA 510(k) eSTAR risk requirements?
Yes. The risk management files I construct directly feed into the risk documentation requirements within the FDA eSTAR software, covering residual risk evaluations and risk-benefit conclusions.
Do you cover software cybersecurity risks?
Yes. For connected devices and SaMD, I integrate cybersecurity vulnerability analyses and risk assessments compliant with AAMI/ANSI/UL 2900 and current FDA cybersecurity guidance.
What is a Risk-Benefit Analysis (RBA)?
When individual residual risks or overall risk profiles exceed standard acceptability thresholds, an RBA provides clinical evidence proving that the medical benefits outweigh the residual risks.
Can this documentation be audited by ISO 13485 registrars?
Yes. The deliverable is fully formatted for your Design History File (DHF) and will pass notified body audits under ISO 13485:2016 clause 7.3.
