Manufacturing neurovascular (NV) catheters requires taking into account clinical performance considerations that go beyond what’s required for other types of catheters. To embed those considerations into the design of NV devices, manufacturers need the right set of development and manufacturing capabilities. Further, designing NV catheters involves important considerations around material selection, model testing, and early […]
Whitepapers
Simplify FDA 510(k) Submissions – Get Answers From Our Expert!
Navigating FDA 510(k) Submissions can be challenging. While the process may not always be swift or seamless, Intertek’s dedicated team is here to significantly enhance your experience. To help ensure your submissions move in the right direction, we’re pleased to offer answers to Frequently Asked Questions. Download the FAQ now!
The Future of Robotic-Assisted Surgery in Orthopedics
No doubt, manufacturers of large surgical robotic systems have dominated the first era of robotic surgery. In orthopedics such systems have been acquired by the dominant implant companies and have been used to obtain long term implant performance. But the next era of surgical robotics—both in hard tissue and soft tissue robotics—could open a path […]
8 Medical Design & Technology Trends You Can’t Miss in 2024
Medtech lies at the intersection of two of the most fast-changing and innovative industries—healthcare and technology. Over the past several years, advancements in telemedicine, wearables, and artificial intelligence (AI), have transformed the Medical and Life Sciences industries. As we look ahead to 2024, several key trends are poised to reshape how we design, develop, deploy, […]
Leveraging Real-World Evidence to Differentiate Your In-Vitro Diagnostics
Download this white paper to discover how real world evidence connects data and insights across the total product life cycle to support IVD clinical performance and formulate value narratives for optimizing IVD market access. Download the white paper from Iqvia Medtech to learn more.
Connected Care: Software Reliability
As the number and types of connected medical devices rises, so does the risk to their safety. Constant threats from a widening collection of contributors have compelled manufacturers to view security as a core product attribute, including: Protecting devices from external attacks such as viruses, worms and ransomware Protecting confidential patient data Updating devices securely […]
SigmaTron International’s Latest Whitepaper on Outsourcing Strategy
As component availability improves, original equipment manufacturers (OEMs) are starting to rationalize their outsourcing strategy. Not surprisingly, interest in shortening supply chains and avoiding geopolitical risk is influencing a lot of those decisions. Mexico’s shared border with the US continues to make it an attractive nearshore option. However, Southeast Asia and China still represent viable […]
Accelerating MedTech R&D with Specific Device Data from EHRs
Studying the comparative effectiveness of medical devices with real-world data from claims and chargemasters is problematic because, unlike drugs, specific device information is not included. With its rich clinical context and granularity, EHR data can change this. In this whitepaper, learn how MedTech companies can accelerate R&D with clean, complete data from 30+ US health […]
Medical devices must comply with home healthcare safety and performance standards
Medical device manufacturers must consider the differences between a device used in a professional setting versus one used in the home. The users, environments and risks are quite different. This paper explores those variations and how testing helps you comply and capitalize on the fast-growing home healthcare opportunity. Please complete the form below to download […]
Lithium Ion Cycling Charge and Discharge
In this new report, we explore the cycling and performance characteristics of various-sized batteries under different conditions and highlight the performance of Resonetics lithium ion cells manufactured for implantable medical applications. Read now via the form below.
Regulatory Transformation Demands New Business Cases and KPIs
Medical device regulations continue to grow more complicated. For regulatory affairs departments to manage the ongoing challenges in workloads and regulator expectations, organizations are going to have to start planning for change. Learn Cook Medical’s and Exact Sciences’ top suggestions for tackling regulatory challenges and igniting changes needed within your organization, including: How to build […]