Originally Published March 14, 2023
By Erica Kramer, Ph.D.
This article looks more closely at the literature review process for EU MDR compliant clinical literature evaluations. Get the article here.
The New Post-Market Surveillance Regulations for Europe – Part 3: Trending, Analysis and Documentation
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.
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.
Nerac Announces the New Issue of the Nerac Strategist
Originally published November 17, 2017
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