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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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
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
Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond
By Ron Sills & Donna Mitchell-Magaldi, Nerac Analysts
Originally Published: September 26th, 2014
Our medical device team is at the Regulatory Affairs Professionals Society conference in Austin, TX and early reports are that the EU will be pushing hard on Notified Bodies to increase the demands on Medical Device Regulatory Affairs submissions. As a result, we feel that auditors will be much more critical in their inspection, so it is imperative that you keep your clinical literature evaluations and updates current.
We invite you to download our free white paper “Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond” to learn more about how we can help. Read more
Utilizing the FDA Website for Competitive Intelligence Information
By Donna Mitchell-Magaldi, Nerac Analyst
Originally published April, 2014
There are many resources available when gathering competitive intelligence. Read more