Medical Devices Walt Medical® P•S•S ’s and Mr. LeMahieu’s Experiences & Capabilities are extensive, as seen presented throughout the site - predominantly the complex field of Electro-Mechanical & Embedded Software Medical Devices & Systems. Decades of Product Experience & Capabilities Our clients can be assured that “Expert, Advanced or Competent” skills as are required will be applied to each Client’s Engagement as agreed. Our Device Expertise Cardiac Devices • Pacemakers • Defibrillators • ICU/CCU Cardiac Monitors • Oxygen Saturation Monitors Diagnostic Devices • In Vitro Diagnostics (IVD) • Glucometers • Telemedicine Solutions • Electronic Stethoscopes Therapeutic Devices • Drug Delivery Systems • Ambulatory Infusion Devices • Respiratory Devices • Dermatology Devices Comprehensive Product Realization Services Design & Development Complete product development from concept through design validation and verification Quality Management ISO 13485, ISO 9001, and FDA QSR compliance and implementation Regulatory Strategy FDA 510K, PMA, and EU CE Mark submission strategy and execution Testing & Validation Verification, validation, and compliance testing in our confidential laboratory Ready to Bring Your Medical Device to Market? Let's discuss your device development and regulatory needs Client Prospects CLICK to get Started! CLICK to See more Success Stories! Sales Affiliates CLICK to Contact Us! · Walt Medical® P•S•S · Founder’s Prior Experience · Walt Medical® P•S•S & Founder’s Previous · Medical Devices Experiences · 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) · 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) · 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) · 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) · Manufacturing Experience · 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) · 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) · Test Experience · Numerous Products & Classes, PWA & Device (TUV, Intertek, UL, CSA Intl, D&D & Production) · Numerous Products & Classes, PWA & Device (TUV, Intertek, UL, CSA Intl, D&D & Production) · Standards Experience · ISO (13485, 14971, 9001, 15223, 20417, 11137, 11607, 15378, 22716, 22715, 17516, 21148, 14644, 10993, etc.) · IEC (60601, 62366, 62471, 60825, etc.) · ISO (13485, 14971, 9001, 15223, 20417, 11137, 11607, etc.) · IEC (60601, 62366, etc.) · Regulatory Experience · 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) · FD&C Act, Class I–III 510(k) / DeNovo (US FDA)