Orthopedic Implants
Hemorrhage Compression Tourniquets
Nerve Block Catheters
Pulse Oximeters
Urinary Catheters
Wound care devices
SaMD
SiMD
Clinical Decision Software
Precision Syringes
Liver Perfusion Devices
microneedling Pens
Custom Devices
infusion pumps
Blood Pressure Manometer
general wellness products
Case examples
Revision knee and hip implants · Orthopedic
Three implants changed geometry or sizing compared with their predicates: a higher-constraint revision knee insert, porous titanium knee cones, and a cementless hip stem. I built the predicate comparisons and mapped the testing to recognized standards, including ASTM F2083, F1223 and F1800, ISO 7206 and the MR Conditional labeling suite. Outcome: three Traditional 510(k) clearances in 59, 76 and 84 days, on bench data alone.
Junctional hemorrhage control tourniquet · Cardiovascular
A redesigned tourniquet with a one-handed ratcheting strap, a new bladder shape and a longer wear time, plus a new indication for pelvic fracture stabilization. As the client's fractional regulatory manager, I built the predicate comparison and supported it with pressure-hold, bond-strength and biocompatibility testing. Outcome: cleared with the expanded indication.
Voice restoration surgical kit · ENT
A kit for creating a tracheoesophageal puncture and placing a voice prosthesis after laryngectomy. The submission included a cadaver usability study with 15 users per IEC 62366-1, EO sterilization validation, shelf-life and packaging testing. Outcome: cleared with no animal or clinical studies.
Medical image fusion software (SaMD) · Radiology
The software left out features its predicate had, such as manual editing of deformable registration. We justified each difference with published guidance and backed it with software verification and validation in a simulated clinical setup. Outcome: cleared in 121 days with no clinical study.
Ophthalmic electrodiagnostic system · Neurology
An active, software-driven device that touches nearly every standard at once: IEC 60601 electrical safety and EMC, IEC 62304 software, IEC 62366-1 usability, ISO 14971 risk, light hazard and biocompatibility. Outcome: cleared in 186 days.
Infusion pump system remediation · General hospital
Regulatory guidance and remediation submission writing, as part of a cross-functional team, for a modular infusion pump system following recalls and design changes. Outcome: cleared after an extended, multi-round FDA review.
Sharps container · General hospital
Built around ISO 23907-1 with independent penetration-resistance and spill testing. Outcome: cleared in 55 days.
Earlier in my career: a ceiling-mounted LED surgical light, and three women's-health devices for tubal and uterine evaluation, including a Special 510(k) cleared in 30 days.
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