Our Services In all our Industries Walt Medical® P•S•S provides comprehensive services related to Design, Development, Quality, Reliability, and Regulatory - from concept through market. In our Industries of Medical Devices, OTC Pharma, and Cosmetics, our services include Design & Development of the Product, Test Systems and Manufacturing of Products themselves. In Home Care, Services are more limited to Consulting and Contracting regarding Product Usability, Use Environments, and Care services (typically excluding product design & manufacturing). Our Engagement Models CLICK to see our Business Definitions EM1: Consulting Expert Advanced Many Clients require simply Consulting for the demanding problems. Or, they require Consulting at the outset of an Engagement because they have not developed Requirements (Specifications) and cannot properly understand the Scope of their own effort — address high-level questions, establish Project and Product requirements, to a signed Agreement/Contract. For these we offer our Consulting, on a Retainer basis. President and Founder, Mr. LeMahieu brings a substantial Product program & project management, design, development, quality and quality management systems, reliability, regulatory, risk management, compliance expertise and leadership. Request Consulting → *Valid Client-prospects only please - no obligation. EM2: Contracting Expert Advanced Competent Contracting is a substantial area of focus for Walt Medical® P•S•S (see also Consulting). With an accepted RFQ, then Quote, then Contract, we work to succeed, in what we hope will be a long-term relationship …“Concept thru Market!™” Our Specialists are hand-selected, screened, and highly characterized by skills and experience, selectable by your region and price range. Either by your RFQ, or with you in a Consulting “scoping” effort, together we make sure the right human resources and skills are applied, at a price you can afford. Request Contracting → *Valid Client-prospects only please - no obligation. EM3: Staffing Expert Advanced Competent Staffing is also a substantial focus of Walt Medical® P•S•S. It’s even an exit strategy for our Contractors! We provide half-time (HT) to full-time (FT) Staffing resources, typically on one (1) to six (6) month assignments, to meet your onsite need for high quality human resources to your specifications. Our Specialists are hand-selected, Reference & Background checked, with validated Personality/Performance, CV/Resume & Training records, and a signed Independent Contractor Services Agreement (ICSA) under our Business Ethics & Conflict of Interest Policy . Request Staffing → *Valid Client-prospects only please - no obligation. Our Service Disciplines For each Engagement type above, we offer the following three broad Disciplines SD1: Product Design & Development End-to-end product development from concept through market launch. Design, development, prototyping, testing, and manufacturing support using latest technologies and best practices. CLICK to Learn More → SD2: Quality Quality management systems implementation and certification. ISO 13485, ISO 9001, FDA QSR compliance, design controls, and risk management processes. CLICK to Learn More → SD3: Regulatory Expert regulatory strategy and submission support. FDA 510K, PMA, EU CE Mark, and global market approvals. Product classification and compliance planning. CLICK to Learn More → And consider Walt Medical® P•S•S as your One-Stop Provider! Walt Medical® P•S•S has significant experience and capability with our Resources, in our Industries, and Disciplines. Let’s discuss up front how we can reduce the number of Suppliers you work with! We will suggest a clear plan with you. Or let’s execute an initial Project together, and succeed, and then discuss growth together. We’re capable of taking on multiple Projects simultaneously if useful! Regardless, our Clients almost always request us to participate in follow-on and bigger Projects. Let us demonstrate our S