From rapid prototyping and IEC 60601 compliance to global regulatory submissions — every service we offer is grounded in real engineering experience. We solve the hard problems and get your device to market.
Most regulatory consultants know the rules. We know how to build the devices that follow them. That combination — deep engineering skill paired with regulatory mastery — is rare, and it's why our clients pass.
When your device stalls at a design challenge — EMC failures, leakage current, isolation issues, FMEA complexity — we diagnose and fix it. We're engineers who know compliance, not compliance people who dabble in engineering.
Regulatory strategy that ignores engineering reality wastes time and money. We design with the submission in mind from day one — right material selection, right architecture, right test plan — eliminating costly late-stage redesigns.
We know what Intertek, UL, TÜV, and CSA engineers are looking for — because we've been through it dozens of times. We prepare your device so there are no surprises when it counts most.
We bring hands-on product development experience to every engagement — the kind that comes from actually building medical devices, not just reviewing documents about them.
From concept to functional prototype — fast. We compress design cycles while keeping compliance baked in from the start, not retrofitted at the end.
Engineering-driven failure mode analysis — component and system level. We build risk files that satisfy FDA, EU MDR Annex I, and your Notified Body.
EMI/EMC issues, electrical isolation failures, leakage current, biocompatibility questions, usability blockers — we diagnose the hard problems that stall development and fix them.
Electrical safety, EMC, biocompatibility, and sterilization requirements embedded in your specs early — so your device is compliance-ready before testing begins.
Test protocol development, execution support, and DHF-ready results documentation built to withstand FDA design control and EU MDR Annex II/III scrutiny.
IEC 60601-1 is among the most complex and frequently misunderstood standards in medical device development. We've spent years mastering it — not just for documentation, but for actual circuit design, isolation strategies, and hands-on pre-compliance testing.
When your device needs to navigate leakage current limits, creepage and clearance distances, MOPP/MOOP classifications, applied parts hierarchy, or SFC analysis — we've done it dozens of times across capital equipment and disposable devices.
Capital & Disposable Device Experience — From high-voltage capital equipment and electrosurgical generators to single-use disposables and wearable sensors, we understand the distinct engineering challenges, testing requirements, and regulatory pathways each demands.
Test house failures are expensive, demoralizing, and avoidable. We prepare your device — technically and documentarily — so you walk in ready and walk out cleared.
Before you book a test slot, we review your device against IEC 60601, EMC, and applicable standards. We catch design-level failure risks before they become expensive lab failures.
We develop a bench-level pre-compliance plan so you can identify leakage current, EMC, or isolation problems on your own equipment — not at $1,500/day test house rates.
We prepare the complete documentation the test house needs — risk file, essential requirements checklist, device description, test configurations — so there's no back-and-forth delay.
We attend testing with you, interpret results in real time, and rapidly advise on engineering fixes if something fails — keeping your project moving rather than waiting weeks for a new slot.
Test reports flow directly into your FDA or CE marking submission. We write the technical documentation linking your results to applicable standards and regulatory requirements.
Common tests we prepare for: Electrical safety (IEC 60601-1), EMC (IEC 60601-1-2 / FCC / ICES-003), biocompatibility (ISO 10993), usability (IEC 62366), sterilization validation, software (IEC 62304), and environmental (IEC 60068).
Engineering expertise alone isn't enough — you need it paired with deep regulatory knowledge. We cover the full global landscape, every device class, every risk tier.
Start with a free 30-minute discovery call — we'll map out exactly what you need.