Walt Medical-portfolio

GLOBAL PRODUCT DESIGN, DEVELOPMENT, POST-MARKET EXCELLENCE—Concept thru Market!™

Engineering (EE, ME, SWE, IE, Opto) — Project & Program Management — Quality Management & Systems — Regulatory Affairs Management — Manufacturing Transfer — Pre-Clinical/Clinical Research/Studies (PhD, MD)

IMPLANTABLE - HOSPITAL BEDSIDE - ICU/CCU - AMBULATORY - MOBILE - HOME

US/FD&C Act/cGMP/MDSAP • EU/MDD/MDR • CAN/CMDR/CMDCAS/MDSAP • ISO • IEC • AAMI • ANSI • ASTM • [WM Editions!]

TO OUR CLIENT's STAKEHOLDERS, WE ARE:"a HAND4 Life! ®", and "Supporting YOUR Living!"®

Portfolio

OEM Products & Test Systems Group

Prior to joining Walt Medical, its Specialists had distinction of working in some of the most esteemed companys, and the people in them — in the medical, cosmetic and pharmaceutical industries.

We are firstly a team of seasoned veterans, have led or substantlally participated in, a significant number of high-technology product design, development and marketing efforts.

We intend to bring our expertise to your Projects, with strict confidentiality (Client, product(s), human resources - mentioned only with written permission).

Please send your Letter of Interest, or detailed RFQ, for our consideration. We would like to discuss your needs, and pursue mutually beneficial opportunities!

ICU/CCU Cardiac Monitor + x02 Oxygen Saturation

Program Management. Analog Design. Embedded Systems. Quality Engineering & Management. Regulatory Approval - US 510K

Drug Delivery/Infusion, + Ambulatory

Program Management. Embedded Systems. Quality Engineering & Management. Regulatory Approval - US 510k.

Home Health POTS/VOIP Electronic Stethoscope

Program Management. Analog Design. Embedded Systems. Quality Engineering & Management. Regulatory Approval - US 510K

Class I/ II/ IIb Dermal Roller, Drug Delivery, Collagen

Program Management. Quality Management, Medical Device QMS, OTC Pharma QMS. Cosmetics QMS. Regulatory Approval - EU CE Mark, US 510K (pending).

Product Development Products

Quality Management Systems - Walt Medical Editions!

Walt Medical has developed Walt Medical Editions!, a line of Quality Management system Products (currently 5 Series, 4 Volumen) for Small & Startup Companies, and particularly Low-Medium Risk Class Products [I/II (US); I/Is/IIa/IIb; I/II/III (CAN)]

These have been designed to be flexible for Legal Manufacturers, our Clients, and for rapid Certification by accredited bodies (e.g. ISO Registrars), and Competent Authority Registration and Licensing (including review by Regulatory/Notified Bodies.

We believe these new Products are of high-value and enablee rapid readiness, Certification, and market adoption in large territories globally. We are a full-service Organization commmitted to developing a successful, profitable Product line for the Marketplace, and thereby, assure our own success and profitability.