By Rosemarie Szostak, Ph.D., Nerac Analyst
Originally published November 13, 2018
The holy grail of AI in healthcare is in improving patient outcomes and reducing healthcare costs. However, the primary stumbling block for AI in medical devices has been the FDA.
Read the article here.
Established and Emerging Applications of 3D Printing in the Medical Field
By Mary Becher, Nerac Analyst
Originally published June 7, 2018
This article explores current applications of 3D printing in the medical arena as well as what’s out on the horizon. Read more here.
The European In Vitro Diagnostic Regulation: It’s Time to Start Preparing
By Erica Kramer, Ph.D., Nerac Analyst
Originally published November 14, 2017
This article explores the EU In Vitro Diagnostic regulations and the changes manufacturers face. Read more here.
Nerac Adds Skilled Professionals to its Medical Device Practice Group
Originally published August 16, 2017
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Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A 3-Part Nerac Perspective
By Richard Conforti, M.S.
Originally published August 15, 2016
This is a 3-part series of articles on the 2014 Chinese Food and Drug Administration(CFDA), providing an update on their medical device regulations. The first article discussed which devices can be used to support your submission to the CFDA. The second article addressed the changes to selecting clinical literature. The third article describes the final clinical literature report.
Read all three here
Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective, Part II: Selecting the Best Clinical Literature
By Richard Conforti, M.A.
Originally published June 14, 2016
This is the second article on the 2014 Chinese Food and Drug Administration(CFDA), providing an update on their medical device regulations. The first article discussed which devices can be used to support your submission to the CFDA. In this article we will discuss the changes to selecting clinical literature.
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Commercialization Strategy for Innovative Products: The Importance of Considering Regulatory Implications
By Donna Mitchell-Magaldi, M.S., Nerac Analyst
Originally Published: March 8, 2016
You have a great idea for an innovative product, a granted patent, and you are ready to assess market and commercialization feasibility, but do you know the important questions you will need to answer?.
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Risk Assessment and the Value of a Comprehensive Post-Market Surveillance Program
By Carol Young, Nerac Analyst
Originally Published: January 20, 2016
This article explores risk assessment and the value of a comprehensive post-market surveillance program.
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Patents and Medical Devices: Protecting your Business Through Intellectual Property
By Ron Sills M.S., Nerac Analyst,
Originally Published: July 6th, 2015
This article describes how medical device manufacturers can and should protect their products and business interests through patent protection. This includes not only patent protection of their own intellectual property, but actively monitoring the industry to ensure there is no infringement on their intellectual property.
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MedTech Member Meetup
Join fellow MedTech members for this Member MeetUp to hear several engaging speakers discuss cutting-edge developments and opportunities for partnering, receive a tour of the facility and network with your peers. AGENDA 1:00 pm Member arrival and registration 1:30 pm Presentations Brian McIlroy, Commercial Healthcare Leader, GE Idea Works Joseph Grohowski, Founder and President, Praxis […]