Assembling a team for an efficient preclinical studyWhen it comes to kicking off your preclinical study, assembling the right team will help you anticipate challenges and implement solutions that will help your study progress efficiently, saving you time and...
Scope of Statistical Applications in Risk-Based Quality Management (RBQM)
Risk-based quality management (RBQM) represents a core area of clinical development that systematically focuses on both safety and data quality risks across the clinical trial lifecycle and is increasingly expected by regulatory agencies. The European Commission...
How to Design an Efficient Preclinical Testing Study
A medical device's pathway from concept to commercialization can be fraught with pitfalls, setbacks, and a need to recurring, significant investments. Our preclinical teams are often asked by prospective sponsors for in-vivo preclinical studies that are premature....
What is Fast to Proof-of-Concept?
We see a continued need from our clients, both large and small, to partner with organizations that can deliver meaningful and actionable solutions focusing on usability, design, and engineering in phase 0 through phase 2 front-end engagements. That’s why we offer a...
Leveraging AI and ML in Medical Products – Part 3
Bob Bouthillier Director, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence (AI) and machine learning (ML) today, its potential across a variety of applications, an analysis of challenges faced by...
How Confounding Forces Impact Medical Device Development
Bob Bouthillier Director, Electrical Engineering, Veranex We live in a time where we have easy access to biometrics that help both our clinicians and us manage our health. Some of these biometrics include the following: O2 saturation and heart rate via pulse...
Leveraging AI and ML in Medical Products – Part 2
Bob BouthillierDirector, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence (AI) and machine learning (ML) today, its potential across a variety of applications, an analysis of challenges faced by...
Leveraging AI and ML in Medical Products – Part 1
Bob BouthillierDirector, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence (AI) and machine learning (ML) today, its potential across a variety of applications, an analysis of challenges faced by...
Building Blocks of Quality: The Role of Design Control in Medical Device Development
Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product that can be consistently and reproducibly produced for commercial use. The process uses a systematic approach to define...
Achieving Regulatory Clearance for a Novel Device – Provisio Medical
Provisio™ SLT IVUS™ System Creating a novel medical device typically includes innovation around treatment, capabilities, cost reduction, or usability that results in improved patient outcomes. It also requires working with regulatory authorities to determine which...