A quick independent review of your risk management documentation
Find and correct problems before an FDA submission and before an audit
Challenges
Leaders across Engineering, Program Management, Quality and Regulatory often face:
- Unexpected Audit Findings: Risk management is cited in multiple audits, driving recurring CAPAs and rework.
- Submission Pushback: Teams struggle to clearly answer FDA reviewer questions about hazards, risk controls, or residual risk justification.
- Unclear Processes: The Risk Management File feels fragmented or outdated, raising concerns that it is not ready for a regulatory submission or audit.
- Challenges Post-Market: It is complicated and laborious to keep the Risk Management File up-to-date
These issues create uncertainty, slow down development, and increase regulatory risk, especially for software-intensive and connected medical devices. Our service identifies these gaps before they become escalation points.
What is the Risk Management Spotlight service?
We offer a quick way to get an independent review of your Risk Management File and procedures to make sure you’re ready for an FDA submission or future audit. For a fixed price, we review your quality system procedures and product risk documentation against the requirements of the ISO 14971 risk management standard and related guidances, including software and cybersecurity considerations.
Within two weeks, we deliver a clear, actionable gap analysis report that highlights what is missing, incorrect, or unclear at both the SOP and Risk Management File levels. We assess the adequacy of your procedures, risk acceptability criteria, hazard identification methods, risk assessments, risk control traceability, and the completeness of your Risk Management Report, including evaluation of residual risk and Benefit-Risk Analysis.
Meetings: we will conduct a kick-off meeting with you to discuss any special concerns you have and a closing meeting to thoroughly discuss the gap analysis report and answer any questions.
More than compliance
This independent review goes beyond compliance. We look for opportunities to improve efficiency, flexibility, and readability so your risk management process works better for your team.
You will receive specific, practical recommendations to improve your risk management procedures and risk documentation. The result is a clearer, more robust, and easier-to-maintain risk management framework that supports safe product development, smoother submissions, and easier audits.
Spotlight Benefits
An independent review helps you proactively identify issues before FDA submission or the next audit, saving time and rework. You get a quick, expert review with clear, practical recommendations. We focus on efficient, systems-based risk management that works for fast-moving teams and modern software-intensive, connected medical devices. Improving your risk management documentation will:
- Speed up regulatory submissions and audits
- Reduce internal friction for product development and post-market
- Help everyone understand “how we make this device safe”
Why Us?
- Deep Expertise: Over 50 years of combined experience in medical device risk management with dozens of Risk Management files, including very complex, software-intensive devices
- Fixed Price, Fast Turnaround: Clear scope, predictable cost, and a two-week delivery. No uncertainty, no open-ended consulting.
- Timing That Fits Your Needs: We perform this review exactly when you need it at key project milestones, before audits, or before regulatory submissions. We are there when the value is greatest and the feedback is most actionable.
Aaron Joseph is a biomedical engineer, systems engineer, and design quality assurance consultant based in the Boston Area. He has over 20 years of experience in medical device development across a broad range of products: surgical robotics systems, laser eye surgery equipment, wearables, medical imaging, drug inhaler devices, catheters, and multiple IOT and SaMD products.
Aaron helps clients with risk management and design controls, software validation, training, and implementation of software tools for documentation automation. He has worked on Risk Management Files and risk management procedures at more than 25 medical device companies.
Joe Sitomer is an experienced and versatile biomedical engineering leader based in the SF Bay Area. Over the course of his long career in medical device development, he has filled many roles including software engineer, program manager, systems engineer, and engineering manager. He has worked on dozens of medical device projects including innovations in medical imaging, cardiology, medical information systems, and surgical robotics systems. His experience includes a wide range of environments including small and large companies, startup environments, and academics.
Over his career, Joe has developed a pragmatic approach to compliant medical device development without stifling innovation or productivity. His focus on systems thinking, reusability, and scalability have helped drive multiple successful product launches. He promotes a “shift left” philosophy for accelerating medical device development and smoothing regulatory submissions, including risk management, requirements management, human factors, and cybersecurity.