Projects Walt Medical® P•S•S has performed successfully and substantially in a substantial number of Projects over the years. This page is meant to show you both our “Summary Successful Projects Listing”, and just a few interesting (randomly selected) Projects completed. Successful Project Summary Listing Click the button for a fuller listing (though in brief) of Walt Medical ®   P • S • S Projects. CLICK to See our Success Stories! Microneedling Rollers & Pens Dermatology Medical Device Cosmetic Manual & Electro-Mechanical The Challenge A very small Co relocating from SE Asia, to become “Made in the USA” Manufacturer. No conforming or compliant documentation to begin. Our Roles Lead D&D Program Management & EE, multiple Products & Industries Director of Quality, Regulatory, Supply Chain Management Managed/Led D&D (V&V) & Production Testing (Med-Dev, Sterilization) EU Authorized Representative (for a decade) Outcomes Multi-Million dollar Client Growth. Aided CEO & one Director Ops in below Items, to multi-million dollar Med-Dev line, and companion OTC Pharma and Cosmetics lines (six (6) years); Product D&D. Earliest development, all D&D documentation, Verification, Validations, and Supply Chain; Multi-verse Quality Management System (QMS). Earliest development, all SOPs, multi-product, multi-Class, multi-Jurisdiction, multi-Standard (See Walt Medical ® Editions!); All Internal Audits, QA Plans, led External Audit and ISO 13485 Certification; Regulatory defended (12yrs); USA Export Only Compliance. Earliest stage development, all SOPs, documentation, submissions, Standards, cGMP, QSR/QMSR; developed Technical Files, Submitted 510Ks; EU & CAN Export Compliance, Submission & Post-Market. Same full D&D, QA & RA as in preceding USA case, but applicable Regulations and territories (CE Mark, UK/EU, CMDCAS, MDSAP). A few of our Founder’s former Successful Projects ICU/CCU Cardiac Monitor Critical Care Vital Signs Catheters The Challenge A medical device company needed to develop a sophisticated cardiac monitoring system with oxygen saturation capabilities for critical care environments. The device required FDA approval and had to meet stringent performance and safety standards. Our Roles Program management and project oversight Analog circuit design for sensor integration Embedded systems development Quality engineering and validation FDA 510K submission strategy and support Outcome FDA 510K Approval Obtained. The device successfully cleared regulatory review and is now deployed in critical care units, improving patient monitoring capabilities. Drug Delivery/Infusion System Ambulatory Care ICU/CCU Catheters The Challenge A pharmaceutical technology company sought to develop an ambulatory drug delivery device that would allow patients to receive continuous medication therapy while maintaining mobility and quality of life. Our Roles Program management from concept through approval Embedded systems architecture and development Software validation and safety analysis Quality engineering and design controls FDA 510K regulatory submission Outcome FDA 510K Clearance Achieved. The ambulatory infusion system received regulatory approval and is helping patients receive necessary treatments with greater freedom and independence. Electronic Stethoscope Home Health Vital Sign Telemedicine The Challenge Develop a telehealth diagnostic device that enables remote auscultation over POTS/VOIP connections, allowing healthcare providers to conduct remote physical examinations for home health patients. Our Roles Program management and technical direction Analog audio signal processing design Embedded systems for POTS/VOIP integration Quality system implementation FDA 510K submission and approval Outcome FDA 510K Approval Secured. The device successfully navigated regulatory requirements and is now enabling remote patient care, expanding access to healthcare services for home-bound patients. Invite Walt Medical ®   P • S • S for your next DEMAN