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Specialty Services
Solutions for challenging problems...
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A separate, independent, and objective set of eyes... We can lead, or function as an independent members, of a design review team for human factors, mechanical, electrical and software portions of a device or process.
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Break the stalemate that sometimes stifles design teams and move down the most logical path... Utilizing Pugh Analysis we help design teams create concepts that are innovative, easily manufactured and that satisfy user's needs. This process helps eliminate misdirected efforts that result in projects being behind schedule and over budget.
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Is your idea worth developing? We help our clients create specifications, generate initial concepts, explore user needs, identify regulatory concerns, and generate key data for use in the creation of initial return on investment analyses.
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What is the risk and should we proceed? We help our clients create an ISO 14971 compliant risk management system that identifies, evaluates, mitigates and then tracks hazards associated with a device or process through its' life cycle.
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"It's just good technique..." Leadership and planning to effectively guide a team in the three basic aspects of product development... identification of "WHAT" is required, determination of "HOW" to satisfy the "WHAT", and generation of "PROOF" that the "HOW" satisfies the "WHAT". Design Input... Design Output... Validation... We can lead all or part of a project as well as put existing projects back on track. We will plan, generate specifications, manage resources and create the design history file. All phases of the project are controlled in compliance with design controls.
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