Medical Device and Diagnostics Product Lifecycle

Project examples
PCR Molecular Diagnostic Systems
Collaborative surgical robot
QMS and CE mark for image guided, minimally invasive surgical robot
Rapid concurrent engineering of Texas Breather(tm) emergency use ventilator for COVID-19
Partner
 
 
at The University of Texas at El Paso.
Driving the Additive Revolution

Bessel provides leadership and support throughout the product lifecycle for medical devices, diagnostics, and industrial applications. Bessel engages with clients to deliver complete programs, design and develop new product and service offerings, and to provide quality systems and quality engineering to support the product lifecycle. We plan and help our clients execute manufacturing transfer and scaleup, and successfully enter commercialization. 

 

We establish a state of continuous product and service improvement for our clients based on customer feedback in the commercial (post-market) setting. We can help turn your complaints, CAPAs, and product feature requests into a source of value. 

Our specific practice of combining human centered design with scrum program delivery enhances the performance of teams we help, and is available as a separate training program upon request. In the medical devices and diagnostic arena, we have broad domain expertise by disease state, by complexity of product, and by regulatory pathway. 

 

You might think of us when it comes to Design Controls, Risk Management, Software Lifecycle Processes, Usability Engineering, FDA, and CE Marking. You might think of us when you hear Quality System Regulation (QSR), GMPs, ISO 13485, ISO 14971, IEC 62304, or IEC 62366. We hope you will come to think of us as a trusted partner in your business.

© 2019 by Bessel LLC

Origin, Origin Foundations, and Ethics Guided Design are Trademarks of Bessel LLC

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