By Robert Zott, Director of Advisory Services Development
Originally published September 10, 2018
This article (part 1 of a 3-part series) takes a closer look at the requirements for the PMS system. Read the article here.
The New Post-Market Surveillance Regulations for Europe, Part 1: What to Know and Where to Go
Mastering the Basics: A Primer on 510(k) Submissions
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.
Without Clinical Data, European Compliance Can Appear Unattainable
By Robert Zott, Director of Advisory Services Development
Originally published March 27, 2018
This article helps identify the specific clauses of the guidance document that pertain to clinical data and explores alternative pathways to compliance. Read more here.
EU MDR Timeline
Originally published March 6, 2018
When it comes to the new European Medical Device Regulation (MDR), it’s critical to know where you stand. Take a look at the MDR timeline here.
Beware of Paper Devices: How Clinical Evaluations Can Be a House of Cards
By Robert Zott
Originally published February 7, 2018
This article explores potential pitfalls now faced by device manufacturers regarding CERs and offers guidance on how to navigate these with success. Read more here.
Full Speed Ahead: Navigating the New European Medical Device Regulation
By Robert Zott, Director of Advisory Services
Originally published July 18, 2018
This article takes a look at how the sweeping changes to the new European Medical Device Regulation will impact manufacturers, regulators and auditing bodies.
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.
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.
Read More
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
Webinar: Order 650 – China’s New CLE Requirements for Medical Devices
We invite you to attend our webinar on the clinical literature evaluation process for China.
Learn More Here