Product Design & Development Services Walt Medical® P•S•S provides Product Design & Development services across the entire product development lifecycle. This can begin with R&D projects. Or Initial Product concept, Marketing Plan development and Prototyping. It can continue thru in-depth Engineering Product Design, Development & Testing. Such is intended for Manufacturability and Commercial production. And includes Conformity to Standards & Compliance to applicable Regulations. Lastly, we assist thru Market release, and Post-Market Surveillance. Each Specialist applied brings many years of experience - often decades, in medical device development, and State-of-the-Art technologies and best practices and Usability. Our Product Design & Development Services Every D&D Service listed below in the Client’s Product lifecycle is performed to agreed on Requirements & Scope, and to applicable Standards & Regulations. QA: → RA: → Our Design & Development Disciplines Our Specialists can provide Expert, Advanced or Competent level Skill as required by the Client, in the following disciplines. Ready to Realize Your Product? Client Prospects CLICK to get Started! OR CLICK to Learn more of our Industries! Sales Affiliates CLICK to Contact Us! · Quality Planning · Design Controls · V&V & Process Validation · Risk Management File · Supplier Quality & Production Controls · Post-Market & Records · Regulatory Strategy · Regulatory Assessment · Conformity & Clinical Evidence · Safety & Performance Compliance · Submissions & Market Authorization · Post-Market Compliance · Requirements & Specifications · User Needs & Usability · Marketing Specifications · Product Specifications · Electronic & Component Specifications · Test Specifications · Project & Program Plans · Concept & Prototyping · Advanced Concepts & IP Development · Mathematical Modelling & Simulation · (Rapid) Concept & Prototype Builds · Design & Test Lab Evaluation · 3D Printing & Rapid Prototyping · Verification & Validation · V&V Planning · Verification · Validation · Qualification · Pilot Builds · V&V & Production Test Systems (LabVIEW, C / C++) · Risk & Reliability Engineering · Risk Management & Hazard Analysis (ISO 14971) · FMECA · FTA · Reliability Prediction (MIL-HDBK-217F) · Reliability Testing (MIL-STD-781D) · HALT · HASS & Environmental Stress Screening · Design for Thermal Applications · Manufacturing Transfer & Supply Chain · Design for Manufacturability (DFM) · Design for Test (DFT) · Contract Manufacturer Selection & Liaison · Supply-chain Selection, Contracts, Purchasing, Validation & Audit · Pilot & Volume Production (US, Mexico, Korea, China) · Managed Obsolescence & Product Life-cycle · Environmental Compliance (EU RoHS, WEEE) · Reporting & Design Controls · Technical Reports & Presentations · Design History File Support · Design Controls (QMSR, ISO 13485) · Design Change Control · Root Cause Analysis & CAPA · Analog & Electrical Engineering · Analog & Mixed-signal Design, Concept through Production · Schematic, PCB & PCBA · SPICE Simulation, Worst-case & Monte Carlo Analysis · Bio-sensor Interfacing: impedance, accelerometer, strain, infra-red, capacitive, intra-cardiac, skin · Low-power, Precision Physiologic Sensing & Measurement · Analog Filters & Amplifiers · High & Pulsed Power (IGBT, SCR, FET) · Magnetics: inductive power transfer, chargers, flyback, coils, transformers · RF & Electrosurgical Generation · Battery Hand-held Devices · EMC / EMI Compliance · Optical Engineering · Red & Infra-red LEDs, Emitters, Detectors & Arrays · Bio-optical Measurement (SxO2 Oximetry) · Optical Communications · Beam Alignment, Splitters & Field of View · Lens Materials, Coatings & Apertures · Signal / Noise / Error System Analysis, for Accuracy & Precision · Thermal & Tissue Interface · Optical Packaging · Embedded Systems, Hardware & Software · Embedded HW / SW Architecture · Micro-processors & Controllers (8 / 16 / 32-bit) · Digital Signal Processors (DSP) · PLD / FPGA; ASIC