Insights and analysis from leaders in Medical Device testing, Clinical Research & Trials and Regulatory & Quality Systems Consulting

Each white paper from NAMSA’s experts brings you today’s best practices in medical device testing; from global and regional market analysis to regulatory and clinical affairs. These must-read publications discuss the most pressing industry related issues and provide insights and solutions from some of the global industry’s most sought after experts and thought leaders.

Medical Device Development: Thinking Globally, Acting Locally

Jun 2014

The global healthcare and healthcare service market will maintain steady growth due in large part to an aging population that is living longer and to improved healthcare services in emerging markets that include China, Brazil, India, Japan, Israel, and South Korea, among others. […]

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The Medical Device Industry in Korea: Strategies for Market Entry

May 2014

The Korean medical device market is growing rapidly and presents excellent opportunities in the area of development and distribution of medical devices. Understanding the device market in Korea is critical to making the best of these opportunities, as is a working knowledge of the device registration and […]

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The Role of Continuous Physiologic Monitoring in Preclinical Medical Device Studies

Mar 2014

Preclinical studies in test models can help both researchers and regulators assess the potential effects in humans of new devices and therapies. Continuous 24-hour monitoring using implantable sensors provides data about the effects of a therapy or device on wide array of physiologic and […]

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Impact of EN ISO 14971:2012 on Medical Device Risk Assessment in the EU

Jan 2014

The ISO 14971 standard for medical devices released in 2007 provided manufacturers with a framework to assess and manage risks associated with the use of their medical devices. The European version of this standard – EN ISO 14971 – contains the same normative text as the ISO standard, plus […]

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The FDA Refuse to Accept Policy/Acceptance Review Process

Dec 2013

So you have a 510(k) or PMA submission prepared and are ready to send it to FDA for review . . . or are you? On December 31, 2012, the US Food and Drug Administration (FDA) released two final guidance documents outlining new acceptance review processes that apply to 510(k) Premarket Notifications and […]

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New Legislation in Israel for Medical Device Registration and the Role of the Israeli Registration Holder (IRH)

Oct 2013

In May 2012 Israel’s parliament passed new legislation requiring all medical devices manufactured or marketed in Israel to be registered with AMAR, the Medical Device Division of the Israeli Ministry of Health. According to the new law, applications for registration can be done only by […]

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FDA Regulation of Mobile Medical Apps

Aug 2013 July 2014 (Revised)

The past decade has witnessed rapid advancement in telecommunication and computer technologies. The smartphone is one result of that technological development and has been adopted by hundreds of millions of people worldwide. Innovators in the medical device industry quickly recognized the […]

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Developing a European First-in-Human Study: Three Key Decisions

Jul 2013

A key step in the translational medicine “benchtop to bedside” process model is the move from research and preclinical (in vivo or in vitro) testing to a “first-in-human” (FIH) study. Despite all efforts to predict how the human body will respond—eg, by conducting robust preclinical testing and risk assessments […]

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EU Medical Device Regulatory Framework: Practical Impact of New Regulations

Jul 2013

The EU has the second largest medical device market globally, with emerging technologies typically available 2-3 years ahead of the US market and 5 years ahead of the Japanese market. Two recent high-profile medical device cases have created controversy within the EU medical device regulatory framework and led to a […]

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The Successful Implant: Ensuring Safety and Performance of Medical Devices

Jul 2013

he understanding of the complex reactions involving specific implant characteristics (chemical, physical, and thermal), as well as cellular and secretory factors, collectively determines success or failure of medical devices. Understanding molecular, cellular, tissue, and organ pathobiology, in addition to the principles of […]

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Planning for Successful Medical Device Reimbursement: So Your Device Is Cleared, Now What?

Feb 2013

Congratulations, you’ve received approval to market your device in the United States and possibly international regions as well. Given the time and effort it takes to get approval from a regulatory body such as the US FDA, this is quite an accomplishment. Yet clearance alone does not guarantee a revenue stream. […]

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China’s New Draft Ordinance on Human Genetic Materials and Its Impact on Clinical Trials

Feb 2013

Carrying out clinical trials in China has always been and continues to be a challenge. The application process to get approval in China can in many cases take 9-12 months, with subsequent challenges of gathering and organizing resources, training staff, and setting up new clinical trial sites for the first time. Now there is a […]

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