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ANGIOTECH ATRIEVE
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Stratos Services:
> Manufacturing method identification
> Cost reduction
> Project Management
> Regulatory strategy
> GLP animal studies
> Feasability studies
> Prototype evaluation
> Project documentation
> Product Requirement specification
> Project Plan and Verification
> IQ/OQ/PQ protocols
> Mechanical Engineering
> Quality Engineering
Vena cava filter removal, guidewire manipulation and foreign body retrieval
“This is the second time I have chosen to use Stratos to augment Angiotech’s Product Development resources. Organizationally, they are able to bring to bear key technical resources to help drive projects to successful conclusion in a timely and cost effective manner.”
Senior Vice President Research and Development, Angiotech Pharmaceuticals, Inc.
For Angiotech to meet the optimal market window for its new vascular snare kit, time was a key problem. Angiotech came to Stratos with an aggressive, 10-month project schedule. Stratos quickly integrated into Angiotech’s Vancouver, BC based product development team and helped identify a design solution that cut months from the project schedule, reduced costs and greatly simplified the regulatory strategy. In addition, Stratos identified a manufacturing method (direct metal laser sintering, or DMLS) for creating prototype heat-treat fixtures that enabled rapid evaluation of prototypes and identified techniques for in vitro prototype evaluation. Stratos managed feasibility and GLP animal studies and authored project documents, including Product Requirements Specification, Project Plan and Verification and IQ/OQ/PQ Protocols. All this enabled Angiotech to deliver the Atrieve™ Vascular Snare to market on time and to stay focused on other projects.