Surgical Handpieces
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![MicroFree]()
MicroFree
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![PowerPro]()
PowerPro
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![MPower]()
MPower
Services Provided
Program / Project Management
Risk Management
Systems Engineering
Regulatory / Quality
Verification & Validation
Client Background:
The client struggled with obsolescence, complaints and reliability issues that impacted an entire family of powered surgical devices.
Additionally, an important market requirement was identified: un-tether the product from Mains Power and make the device battery-powered.
Client’s Request(s):
The client enlisted our staff to both improve older products and aid in the development of new battery-powered devices.
For the products on the market, we were enlisted to find improvement opportunities. For the new products, Concise Engineering was contracted to manage their Software Quality aspects of the projects.
Project Actions:
After troubleshooting three distinct product families covered in the scope of work, our staff identified key manufacturing and design-related issues requiring resolution. As a result, we identified and detailed a design solution for each issue.
During the new product development, Concise Engineering fully supported compliance with IEC 62304, aiding in drafting and approval of software test protocols, and managed all aspects of Software Quality for the projects.
Outcome:
This collaboration resulted in a redesign of 3 product families that addressed both obsolescence and the client’s quality/reliability concerns.
With expertise and project management from Concise Engineering, the nascent New Product Development teams developed their first small bone battery-powered handpiece product line, resulting in a new 510(k) cleared device.