By Minh Han, MD, FAAFP, Nerac Analyst
Originally published June 24, 2019
Avengers: Endgame is the highest grossing movie in an opening weekend and it all started with a plan and a storyboard. Marvel Cinematic Universes’ strategy can also be powerful for the Medical Device Universe as well. Read the article here.
The Clinical Evaluation Plan: Creating a Storyboard for a Medical Device
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.
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.
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.