Our Success Stories Walt Medical® P•S•S - and our Founder prior to forming Walt Medical ® P•S•S - have compiled an impressive collection of Success Stories - many Projects & Programs, Device Types, Device Use Environments, Risk Classes, Quality Standards, Regulatory Regimes and Company Scales. ® ')" > * ( ) Have DEMANDING Product Realization Needs?! Client Prospects CLICK to get Started! OR CLICK to Learn more of our Projects! Sales Affiliates CLICK to Contact Us! · Walt Medical® P•S•S Engagements · Mr. LeMahieu has been Key Resource on every engagement to date. · Medical Devices — D&D - Mid / Large Co. & Cap · OEM & Repackager/Relabeler Medical Derma Devices (Private Midsize, QSR/MDR/MDSAP/ISO 13485:16, EE/PM/QA/RA Mgt) · Desktop Mammogram MEDDEV Diagnostic (MidCap, QSR, MDR, ISO 13485:16, QA/RA) · Medical Devices — D&D - Startup / Small Co. · Desktop High-Intensity Focused Ultrasound (HIFU) (Private, QSR, Consultant, Contract EE) · Portable RF Derma Filler Therapy (Private, QSR, EE/PM/QA/RA Consultant) · Wearable Intense LED Wrinkle Therapy (Private, QSR/PM/EE/QA Consultant) · OTC Pharma - D&D - Midsize Co. · OEM Active Ingredient Therapy Monograph (Private Midsize, QSR/MDR/MDSAP/ISO 13485:16, PM/QA/RA Mgt) · Cosmetics - D&D - Midsize Co. · OEM Cosmetics & Devices (Private Midsize, QSR/MDR/MDSAP/ISO 13485:16, EE/PM/QA/RA Mgt) · Medical Device + OTC Pharma + Cosmetics — Manufacturing · Tier III CM — SE Asia — all Volumes Proto, Ckt, HLA/Manual, Test (EE/QA/RA) · Finished Goods-US Site, Contract Sterilization (Mid Co, EE/PM/QA/RA) · Medical Device + OTC Pharma + Cosmetics — Test · Numerous Products & Classes, PWA & Device (TUV, Intertek, UL, CSA Intl, D&D & Production) · Medical Device + OTC Pharma + Cosmetics — Agency / Notified Body · FD&C Act, Class I–III 510(k) / DeNovo (US FDA) · EU MDD/MDR + Pharma + Cosmetics Directives, Competent Authority, · Notified Body, CE Mark, Class I/Is/IIa/IIb · CMDCAS, Class I, II, III (Health Canada) · Medical Device + OTC Pharma + Cosmetics — Standards (as required) · ISO (13485, 14971, 9001, 15223, 20417, 11137, 11607, 15378, 22716, 22715, 17516, 21148, 14644, 10993, etc.) · IEC (60601, 62366, 62471, 60825, etc.) · Founder’s Prior Experiences · Roles held before Walt Medical® P•S•S was founded in 2008. · Medical Devices — D&D - Mid / Large Co. & Cap · Implantable Pacemakers, Defibrillators, Programmers, External Stimulators (Large Cap, USA & Int’l, QSR, MDD, EE) · Cardiac Monitors, Infusion Pumps (US & Int’l, Large Cap, QSR, MDD, EE, PM) · Portable SpO2 Meter (Private, MidCap, US & Int’l, QSR, PM) · Portable Intense LED Derma Therapy (LargeCap, US & Int’l, QSR, Contract PM) · Medical Devices — D&D - Startup / Small Co. · Patient & Central Telemedicine Stations, numerous Medical Vitals Peripherals (Private, Small Cap, USA, QSR, ENG Mgr) · Disposable & Reusable Electronic Drug Delivery Inhaler (Private Startup, US, QSR, Contract PM/EE) · Disposable POC Test, Emergency Response CO2 Meter (Private Startup, US, QSR, Contract PM) · Portable NIOSH Epidemic Drug Therapy (Private, Startup, QSR, PM / VP Ops) · Implant & Wear, Recharge & Inductive Sleep Apnea Therapy (USA Startup, Dir Syst Engr, QSR) · Medical Devices — Manufacturing · OEM PWA/HLA/Test — D&D/Production - all Volumes (US, Int’l, EE/PM) · Tier I & II CM — PWA/HLA/Test — D&D/Production - all Volumes (US, Int’l, EE/PM) · Medical Devices — Product Test · Numerous Products & Classes, PWA & Device (TUV, Intertek, UL, CSA Intl, D&D & Production) · Medical Devices — Agency / Notified Body · FD&C Act, Class I–III 510(k) / DeNovo (US FDA) · Medical Devices — Standards (as required for each Product Type) · ISO (13485, 14971, 9001, 15223, 20417, 11137, 11607, etc.) · IEC (60601, 62366, etc.) · :