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 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.
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.
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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