Whether you are considering licensing a device to deliver your therapy or looking for an independent assessment of your own product, we have 30 years of experience and technical knowledge to review the performance and robustness of your medical device.
Whatever your challenge, we can build a work program to help you assess your specific technology and product area. We employ a suite of tools and processes to comprehensively evaluate a device at any stage of its development, such as:
Analysis and simulation tools such as math modeling, Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) allow us to provide you with a focused, quantitative assessment of fundamental performance aspects of a device.
Formal design for manufacture, assembly reviews, statistical tolerance analysis and cost modeling can provide confirmation – or otherwise – that the system under review is (or could be) viable for your commercial production.
Whether top-down system-level risk, fault tree analysis or bottom-up failure mode and effects analysis, these tools provide robust methodologies for the objective assessment of user, design and process risks.
We perform desk-based expert reviews from analytical assessments (including product conformity assessment) to small-scale user studies. These analyses can provide you with a rich and independent insight into the product’s safety and effectiveness of use.
As a leader in the medical device field, we have built constructive relationships with key companies across the industry, working closely with their technical and commercial teams. This enables us to have detailed conversations and gain access to the information you need to make a thorough technical evaluation of their products before you commit to licensing.
Our team develops a structured approach when conducting your investigation, to make the best use of the time available and ensure we focus on your priorities. Our specialists undertake upfront research and initial evaluation, developing a detailed agenda for discussions, whether it’s a multi-day on-site visit or a series of online meetings.
Through technical audit activities, our experts carefully review the status and robustness of any medical device. Coupled with our experience in device selection and due diligence, we ensure that your target technology meets your needs.
With experience in device selection and due diligence, we ensure that your target technology gives you what you need.
Team has experienced consultants in all the disciplines needed to audit a product:
