The rise of a SMART and connected world brings many challenges, especially as technologies continue to develop and evolve. The evolution of medical devices is no different. With more and more wireless medical devices hitting the market, the need for effective cybersecurity to safeguard patient data and ensure device functionality is critical. Manufacturers must integrate […]
If you’re considering a manufacturing transfer, you may be losing sleep over all the things that could go wrong: cost overruns schedule slips quality issues, to name a few. Missteps anywhere in the process can make the difference between meeting or missing your timeline and budget.
Speed your medical devices to market with this complimentary guide which takes you step by step through the process of submitting your medical devices for approval from the FDA. As a leader in third party testing and certification, Intertek’s industry experts developed this guide to simplify the complex process to submit your medical devices to […]
In today’s SMART and connected world, medical devices are no exception to the world of wireless technologies. In fact, the number of wireless medical devices is growing exponentially. As medical devices evolve, so do the risks. On one hand, we are eliminating wires and cables that previously had to be attached to patients and allowing […]
There’s a formula for effectively managing an adverse FDA inspection and the newest R&Q white paper shares it. Learn all the practical considerations for avoiding regulatory escalation from a former FDA Consumer Safety Officer. Say hello to your free, ultimate guide, that you can download now. In this white paper you will learn: Tips on […]
Micromolded parts continue to get smaller and smaller. They are also getting more precise with details nearly invisible. MTD Micro Molding successfully molded an EVA ophthalmic part that weighs in at about one-tenth the weight of a poppy seed. It is an ophthalmic implant for glaucoma treatment. This feat required MTD’s Sarix technology to make […]
As medical and wellness devices converge, health care providers, mHealth companies, and device makers are facing a number of critical – and increasingly complex – issues, including: Ensuring that patients and HCPs actually use their apps and devices Presenting potentially confusing – or alarming – data so that it is understandable and actionable Unknowingly triggering […]
The Landscape is Changing… The FDA recently finalized their guidance on how human factors and usability engineering should be applied in the design process for medical devices. While this may be new to some, practitioners of user-centered design have known for years that these practices not only improve product safety, they also result in a […]
As medical devices are increasingly connected to central systems within hospitals, numerous cybersecurity challenges have emerged for medtech manufacturers. For example, networked medical devices need to be secured from risks, including hacking and malware. The FDA, as a part of its Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, recommends that manufacturers […]
Medical Grade Qualification Class VI Regulatory Requirements Biocompatibility Defined ISO 10993 Testing Test Strategy Determination Sample Preparation Test Category Descriptions & Assays Case Study Conclusion
For smaller CV device companies seeking to launch or expand their clinical research programs, this paper reviews seven areas of focus for the safest and most expedient path to market. This paper, from clinical research organization Novella Clinical, addresses key factors for smaller device companies to consider when bringing a cardiovascular product to market.