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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