By Robert Zott, Director of Advisory Services Development
Originally published June 7, 2018
This article takes a closer look at 510(k) submissions for FDA clearance. Read more here.
State of the Art for Medical Devices – Applying the Requirements of MEDDEV 2.7/1 Rev. 4
By Sarah Williams, MHA, MHP, RD, Nerac Analyst
Originally published July 31, 2018
This article explores how to establish and document state of the art in terms of CER requirements.
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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
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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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 […]
Notified Body Audit Trends: Be in the Know!
By Donna Mitchell-Magaldi, Nerac Analyst
Originally Published: February 10, 2015
With Notified Bodies being periodically audited, it is important to understand that they will be reviewing your technical documentation with a much more critical approach. As the new regulatory framework is passed and implemented, further changes will increase Notified Body expectations. Auditors will continue to identify areas of concern and medical device manufacturers will need to stay vigilant regarding the findings of the Notified Body auditors in order to keep ahead of the expectations. Make sure you understand these trends!! Read More
Notified Body Audits: Big Changes – Big Headaches
By Donna Mitchell-Magaldi, Nerac Analyst
Originally Published: December 15th, 2014
The new Regulatory Framework for medical devices currently being considered in the European Union will no doubt bring about many significant changes to manufacturers. These changes will encompass stringent Notified Body requirements and oversight coupled with increasing Notified Body authority. These changes will in turn affect your audit experience. Read More
FDA’s Proposed Regulatory Changes to Laboratory-Developed Tests (LDTs)
By Roz Sweeney, Ph.D., Nerac Analyst
Originally Published: November 17th, 2014
The FDA has stated that labs can utilize published clinical data for their submissions. Many LDTs have been on the market for a while and have significant published data. Nerac has expertise in conducting clinical literature evaluations and data analysis to support regulatory filings and ongoing regulatory requirements. Read More
Webcast: In Vitro Diagnostics – Upcoming Regulatory Developments in the U.S. and European Union: Are You Ready for the Transition?
Did you miss our recent webcast “In Vitro Diagnostics – Upcoming Regulatory Developments in the US and EU: Are You Ready for the Transition?” You can listen and watch it here.
In Vitro Diagnostics – Upcoming Regulatory Developments in the U.S. and European Union: Are You Ready for the Transition?
by Roz Sweeney, Ph.D. and Donna Mitchell-Magaldi, Nerac Analysts
Originally published October 2, 2014
Join Nerac analysts Roz Sweeney and Donna Mitchell-Magaldi in this free, interactive webinar providing an overview of the upcoming regulatory changes affecting the In Vitro Diagnostics industry. Read more