Your medical and diagnostic device product lifecycle partner
Radically improve your medical and diagnostic device new product introductions.
Shorten cycle times.
Reduce development costs.
Our clients range from early-stage startups to Fortune 100 companies.
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.
Endoscopic surgical instrumentation
Lateral flow and molecular diagnostics
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.