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Text of the page (random words):
quality engineering simplexity product development iso 13485 2016 certified product development about philosophy team company history awards core values careers portfolio robotics automation biotech consumer devices wearables medical devices physical ai commercial equipment test fixtures disciplines mechanical engineering electrical engineering firmware engineering software engineering systems engineering project management manufacturing engineering quality engineering prototyping new product introduction services full system product development product simplification and cost reduction product feasibility assessments product development research product requirements and architecture explorations prototype development and optimization integrated engineering services product quality management design for manufacturing dfm design for high volume manufacturing expertise mechatronics haptics design embedded firmware solutions printer development test tool development cost reduction and simplification power management gear design and analysis fluidics and microfluidics management internet of things iot design for harsh environments resources product development process hardware self assessment quiz quality and regulatory iso certification engineering and npi templates blog videos webinars podcasts news events publications contact us search icon x search quality engineering quality engineering is fundamental to delivering client satisfaction today s fast moving multidisciplinary products frequently involve complex interactions and timely problem solving every new product that is designed has distinct requirements and simplexity s quality engineering processes have been built to enable close collaboration with our clients to create a product plan that is both risk managed and cost efficient prioritizing the specific needs of the project simplexity s quality engineering expertise includes requirements definition and specification documentation verification activities including test protocols and test reports from product inception through transfer to manufacturing including engineering confidence testing ect builds and testing design verification testing with pre production builds reliability testing regulatory testing proven risk management performing comprehensive data based risk analyses in compliance with iso 14971 managing to simplexity s certified quality management system which is audited regularly both internally and externally by nsf supplier management and performance tracking activities ensure that risk management is also handled upstream by the suppliers further helping to control and manage project risks software and firmware development in compliance with iec 62304 medical device development to meet and test against iec 60601 safety standards electronic qms and client web portal communication to provide direct client access to project documents for download review and approval iso 13485 2016 certification simplexity has been awarded quality management system iso 13485 2016 certification for product design and development related to medical products this iso certification indicates that the company s quality management system qms meets or exceeds the latest international guidance for medical device product development analysis of data on quality system effectiveness supporting continued improvement to our internal quality goals and objectives read more about simplexity s iso 13485 2016 certified compliant quality management system with a constant eye toward meeting client product and regulatory requirements as well as driving continuous improvements to our internal processes our quality engineering team is the hub that keeps product development at a high standard from concept through production case study anavasi diagnostics molecular detector case study reperio health case study sterifre aura simplexity took our complex concept and transformed it into an elegant simple product they have a process for boiling down complex problems into their essence they delivered one solution that is so elegant that we actually display it in our conference room as artwork they delivered a functioning prototype on schedule and budget that wowed our team thanks simplexity scott jewett ceo portable composite structures inc quick links mechanical engineering electrical engineering firmware engineering software engineering systems engineering project management manufacturing engineering quality engineering prototyping npi would you like to discuss your project contact us offices san diego california portland oregon area seattle washington contact us connect careers at simplexity employment verification join our mailing list privacy policy simplexity product development copyright 2026 all rights reserved are you developing a hardware product take our free self assessment quiz production design engineering manufacturing design guidance and ongoing engineering support ongoing quality metrics monitoring optimization the simplexity team can be as involved in the production phase as requested by our clients for clients with internal manufacturing or established relationships with contract manufacturers our engineers are available to ensure quality is maintained and provide ongoing engineering support as needed simplexity has a dedicated new product introduction npi team that can guide the transition from design into production the npi team presents multiple options for manufacturing to the client allowing clients to choose the solution that best suits their needs this can involve simplexity performing initial builds in house prior to full handoff to a contract manufacturer or building the product via established relationships with contract manufacturing partners either domestically or overseas early in the process typical deliverables manufacturing guidance and ongoing engineering support ongoing quality metrics monitoring and optimization phase 3 design verification and design transfer design engineering software design complete hardware pre production units for design verification test design verification test npi mfg readiness cm schedule and budget unit build tracking quality quality metrics verification process process validation support this phase occurs once the detailed design is complete and prototypes are built with manufacturing representative quality and detail more extensive formal testing is performed such as life reliability safety environmental drop and vibration the design team works closely with the manufacturing team to enable a smooth transfer often with simplexity engineers traveling to the contract manufacturer sites to ensure product quality the design is transferred to the client based upon specific needs most often after all tests are complete and the design is verified typical deliverables pre production units formal verification test reports design transfer package including design history file dhf if needed for fda submittal process validation support unit build tracking contract manufacturing schedule and budget quality metrics verification gate definition design verification complete phase 2c detailed design prototype 2 design engineering software full feature implementation hardware prototype 2 units with production representative materials and processes test engineering confidence test integration test npi mfg readiness cm onboarding design transfer prep quality build quality plan 2c prototype 2 design build and test phase 2c iterates on the learnings of phase 2b and involves a refined prototype build of a fully integrated system some projects also benefit from additional iterations of the product based on prior learnings through additional phases 2d 2e etc which are not represented in this graphic all requirements are intended to be tested and at the end of phase 2 there will be confidence that the units will pass verification in phase 3 the bill of materials is further refined and the team updates estimates for the per unit cost of the product by receiving pricing from vendors and suppliers typical deliverables updated prototypes software and or firmware binaries and source code updated schematics and layout updated 3d cad files and 2d drawings verification test plans and reports updated bill of materials bom and cost of goods sold cogs build quality plan development design transfer preparation contract manufacturer onboarding gate definition engineering confidence test reviews integration tests phase 2b detailed design design engineering software core functionality implementation hardware prototype 1 units with rapid prototyped components test engineering confidence test unit test npi mfg readiness project build plan cm selection quality critical manufacturing process identification 2b prototype 1 design build and test the detailed design phase usually has multiple iterative sub phases as the design progresses and representative prototypes are built phases 2b and 2c are typically the largest efforts in the product development process where the specific implementation for all disciplines occurs mechanical industrial design electrical firmware systems software manufacturing and quality simplexity typically engages with production component suppliers and contract manufacturing groups early in this phase to provide additional manufacturing input on the design if the product has stringent testing or certification requirements pre screens are performed in this phase prior to formal regulatory agency testing typical deliverables prototypes 3d printed or other rapid prototypes electrical pcas and or preliminary code software and hardware design documentation initial product firmware or software binaries and source code electrical schematics and layout 3d cad files design failure mode and effect analysis test plans and reports project build plan from prototype to pre production initial bill of materials bom and cost of goods sold cogs manufacturing process identification contract manufacturer cm selection gate definition engineering confidence test reviews phase 0 exploration exploration research concept work architecture explorations feasibility study phase 0 is an optional phase for projects where the technical feasibility of the idea has not yet been fully proven it can consist of research concept work exploring initial architecture performing feasibility studies and basic prototyping and testing typical deliverables exploration report gate definition client approval on feasibility of idea phase 1 requirements planing design engineering project plan requirements id ux concepts risk analysis manufacturing strategy identification the business and user requirements are converted into engineering requirements for the product the project planning activity is based on the schedule budget risk and initial product requirements this process is best done as a collaborative team effort with the client who has the deepest understanding of the market needs and user requirements typical deliverables product requirements document project development plan including plans for software firmware electrical quality systems and mechanical risk analysis industrial design id and user interface ui concepts gate definition product requirements document complete client approval of project development plan phase 2 detailed design design engineering software architecture design block sequence and state diagrams hardware major component definition proof of concept subsystems build test characterization and qualification of high risk subsystems components npi quality design for manufacturing tradeoffs evaluation 2a architecture and technology feasability the detailed design phase starts with defining options for the product architecture with the goal of having the greatest chance of successfully meeting product requirements while best mitigating risk engineering activities in this phase include presenting options for hardware components outlining the system block sequence and state diagrams creating rough cad and breadboarding of high risk subsystems results are presented with a description of the pros cons and key tradeoffs for each scenario typical deliverables system architecture design including mechanical electrical and software firmware initial product risk analysis breadboards or proof of concept prototypes of high risk technologies or subsystems id concept models gate definition client approval following hardware and software architecture reviews