Bessel

Your medical and diagnostic device product lifecycle partner 

Radically improve your medical and diagnostic device new product introductions.

  • Shorten cycle times.

  • Reduce development costs.

  • Manage risk.

Our clients range from early-stage startups to Fortune 100 companies.

 

Ready to reach your full potential?
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
And a wide array of Class II and Class III surgical, endovascular, and endoscopic therapeutic devices & capital equipment, lateral flow assays, and molecular diagnostics.

Our client asked for project management help to address costly delays in the transfer of their second-generation surgical device to commercial production. 

 

We helped our client and their contract manufacturing partner shift from traditional, gantt-chart based project management to agile teamwork. This improved communication speed and effectiveness, and the teams regained focus on critical tasks and material availability.

 

Both organizations continue to embrace agile teamwork, and realized lasting benefits from this transformation.  

Clinical Domains

Pulmonary

Cardiovascular

Fertility

Urology

Genomics

ENT

Sleep

Women's health

Technical Domains

Laser surgery

Radiofrequency surgery

Cryovascular therapy

High-performance catheters

Endoscopic surgical instrumentation

Connected/mobile health

Lateral flow and molecular diagnostics

Embedded systems

Functional Expertise
Project Management and Program Delivery ✧ Research & Development ✧ Quality ✧ Operations ✧ Clinical Affairs ✧ Regulatory Affairs ✧ Marketing ✧ Finance

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 products, and to provide quality systems and quality engineering to support the entire 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. 

Think of us when it comes to executing innovative projects from needs-finding through commercial release. We're versed in Design Controls, Risk Management, Software Lifecycle Processes, and Usability Engineering for FDA-regulated and CE Marked medical applications . We can help you navigate the Quality System Regulation (QSR), GMPs, ISO 13485, ISO 14971, IEC 62304, or IEC 62366.

Ready to reach your full potential?