Design. Document. Deliver.
Building Risk-Ready Systems in Early MedTech
August 27, 2025 | Hosted by Grand Avenue Software
Too many early-stage teams treat risk like a checkbox and requirements like a placeholder. And they pay for it later with failed safety certification testing, inefficient traceability that leads to CAPAs, or worse, rejected submissions.
This panel helps you rethink risk and requirements before it’s too late.
Featured Panelists
- Tom Riniker, CEO of Stillwater MedTech, has led global quality and regulatory remediation efforts for device companies facing FDA 483s, Warning Letters, and Consent Decrees. His work spans four continents and decades of hands-on QMS implementation.
- Ed Palmer, CEO of Palmer Wireless Medtech, has spent nearly 20 years leading product development for Class II and III devices, bridging engineering and compliance to help startups build traceable, testable systems even as their designs evolve.
- Steve Cohen, VP of Business Operations at Grand Avenue Software, brings a seasoned executive’s perspective, having led finance and operations at both startups and mid-size companies. He’ll moderate the discussion, helping connect the technical decisions to broader strategic and business realities.
Key Takeaways from the Panel
Build Risk-Ready Foundations
- Treat risk as a living system, not a checklist — wire it into day-one design work and keep it current as the product evolves.
- Standardize the path so teams don’t reinvent process per project; keep flexibility where it matters (design), not in compliance basics.
- Let tools enforce the boring parts (reviews, approvals, link checks) so people can focus on engineering decisions.
Requirements First, Rework Last
- Front-load the effort on user needs, design inputs, and specs; most downstream defects trace back to thin requirements.
- Write requirements to be testable and traceable; if you can’t verify it, you don’t own it.
- Link requirements to risks and verification methods early to avoid expensive redesigns later.
Traceability = Audit Velocity
- Make every link obvious (requirement → risk → test → change). If an auditor needs to “hunt,” you’ll feel it in the room.
- Centralize artifacts; one source of truth collapses answer time from minutes to seconds.
- Walk into audits with confidence: show the chain, don’t explain it.
Change Management that Surfaces Impact
- Redlines show edits, not consequences — always run impact analysis across related requirements, risks, tests, and DHF docs.
- Automate link-checking and notifications so ripple effects are surfaced immediately.
- Capture the “why” for each change; future reviewers should see intent at a glance.
Close the Loop with the Field
- Treat complaints, returns, and service data as inputs to requirements and risk — not as a separate afterthought.
- Trend issues, then tie them back to specific requirements or mitigations and revise deliberately.
- Post-market signals should trigger the same discipline as pre-market findings.
Operate Lean without Lowering the Bar
- Small team ≠ small complexity; let systems carry the workload (links, records, status) so headcount doesn’t balloon.
- Build once, reuse everywhere: templates, risk matrices, verification methods, and review checklists.
- “Ready” reads as credibility — clean DHFs and clear traceability increase diligence confidence.
Practical Guardrails for Teams
- Ship with an out-of-the-box structure (roles, workflows, gate reviews) and tune, don’t invent, the process.
- Default to required fields, required links, and required reviews for critical items.
- Use dashboards to keep ownership and deadlines visible; escalate before dates slip.
Communication, Culture, and Investors
- Communicate status with facts (evidence, links, pass/fail) rather than narrative.
- Show investors your system, not just your story — readiness and repeatability build trust.
- Regulatory strategy is a growth strategy: being audit-ready speeds customer adoption and partnerships.
Ready to Operationalize Your Vision?
If you’re building toward FDA clearance, ISO certification, or commercialization, Grand Avenue Software’s modular eQMS is built for you. Our system scales with your growth and helps you stay compliant without breaking your budget.
Talk to our team to learn how Grand Avenue can help you stay audit-ready, investor-ready, and market-ready.