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SUPPORTING CAPABILITIES
Connected support across development
Catheter programs can require support across multiple disciplines and stages of development. Alentra PD brings together capabilities that can support a program from early investigation and engineering through testing, program execution, quality considerations, and manufacturing.
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+1 617-314-7009
info@alentrapd.com
QUALITY & REGULATORY
Quality That Supports Catheter Development
Quality and regulatory considerations should remain connected to the engineering work as a catheter program progresses. Requirements, risks, testing, documentation, and manufacturing considerations all contribute to building a disciplined development record around the device.
- Design Requirements & Documentation
Maintain defined requirements and supporting engineering documentation as the design evolv - Risk Management
Identify and evaluate risks throughout development and use findings to help inform design decisions. - Testing & Evaluation
Develop appropriate methods for evaluating device performance and documenting results. - Manufacturing Considerations
Connect design decisions with assembly, process, and manufacturing requirements as development progresses.
Ready to move your catheter program forward?
Talk with Alentra PD about the engineering, development, testing, quality, and manufacturing needs behind your catheter-based or endovascular device program.