Next-generation sequencing (NGS) assays sequence the genes in human biological samples making them a unique subset of in vitro diagnostic devices (IVDs). Unlike other IVDs, NGS test results… Read More
Exploring emerging technologies and commercial applications in the field of therapeutic ultrasound
The history of ultrasound devices goes back to the start of the twentieth century, when… Read More
Pediatric medical devices are critical for proper medical care of children.
The connection between innovation and realization of pediatric medical devices is a challenging one as th… Read More
Making the decision to adopt a baby chameleon hatchling comes with excitement and also the responsibility of ensuring you have the correct environment needed for them to thrive. We have sev… Read More
Under the EU MDR, literature reviews are recommended components for clinical evaluation, post-market surveillance, post-market clinical follow-up, and PSURs. The need to review scientific li… Read More
The state of the art evaluation is a necessary component of Clinical Literature Evaluations (CERs) based on the European Union (EU) Medical Device Regulation (MDR), In Vitro Diagnostic Regul… Read More
Have you struggled to develop your search strategies for the state of the art evaluation? Are you finding yourself sorting through large amounts of data? This article outlines best practice… Read More
A large fraction of Digital Transformation efforts fail to deliver their promised value. Many of them cause frustration, anger, and distrust. Leadership accepts several reasons, rarely inclu… Read More
Medical device literature reviews for EU CERs present a challenge to many manufacturers. The literature review component of your CER will undergo robust scrutiny by the Notified Bodies… Read More
The claims a manufacturer chooses to make about its medical device are an important aspect of the product and are closely tied to its safe use and optimal performance. Device claims are… Read More
It has been two decades since scientists learned to mimic the ability of the gecko to adhere to any surface reversibly. The critical question is whether this biomimetic technology has found… Read More
When a manufacturer desires to make a change to a Class III device that has been approved via a Premarket Approval (PMA) or product development protocol (PDP) that affects the device’s… Read More
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This article explores how an in-depth market study of alternative consumer packaging including target audiences, sustainable practices and social values, can arm companies with the insight t… Read More
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Clients trying to understand how their business is evolving can benefit from taking a step back to look at the current state of intellectual property. A patent landscape analysis helps N… Read More
What keeps you up at night? Staying on top of your industry sometimes feels like you are drinking water from a fire hose. It is a Herculean task to keep up with all the information that is o… Read More
The COVID-19 pandemic shook the world, and forced scientists to develop a vaccine rapidly, foregoing all normal protocol. Post-Market Surveillance of adverse events became a critical element… Read More
Perhaps the smartest way to be prepared to serve customers in the future is by anticipating their needs. Being a few steps ahead of a client can be a recipe for success and arriving at this… Read More
By Nerac IP Analysts
Originally published July 28, 2020
Changing industry demands and new business challenges are also offering unprecedented opportunity. Whether it’s sudden disrupti… Read More