By Robert Zott, Director of Advisory Services Development, Nerac Analyst
Originally published February 15, 2019
This article (part 3 of a 3 part series) examines trend reporting (Article 88 of the MDR), the analysis of serious incidents and field safety corrective actions (Article 89), and the technical documentation requirements for PMS (Annex III).
Read the article here.
The New Post-Market Surveillance Regulations for Europe – Part 3: Trending, Analysis and Documentation
The New Post-Market Surveillance Regulations for Europe, Part 2: Serious Incidents Get A Serious Overhaul.
By Robert Zott, Director of Advisory Services Development
Originally published November 13, 2018
This article (part 2 of an ongoing series) examines the reporting of serious incidents and field safety corrective actions described in article 87.
Read the article here.
From Hal to Wall-E: Artificial Intelligence is transforming the medical device industry
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.
The New Post-Market Surveillance Regulations for Europe, Part 1: What to Know and Where to Go
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.
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.
Medical Devices: New Applications for Old Innovations
By Helga Weires, Nerac Analyst
Originally published June 19, 2017
This article explores new applications for old innovations in medical devices.
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Regenerative Medicine: A New Kind of Cellular Service
By Tyler Stahl, M.S., Nerac Analyst
Originally published April 27, 2017
This article explores recent trends in the developing field of tissue engineering and regenerative medicine.
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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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The Regulatory Environment for 3D Printing in the Healthcare Field
By Erica Kramer,Ph.D., Nerac Analyst
Originally published January 19, 2017
Learn more about 3D printing in the medical field and and key conclusions on regulatory issues in the healthcare market.
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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