Regulatory

NGS Assays: Here are the Variables of Clinical Performance

Originally published Sept 8, 2023
By Sarah McLeod, M.S., Regulatory Analyst/Medical Writer

Next-generation sequencing (NGS) assays provide a clinically valid resource for precision medicine. Knowing how NGS assays perform on different regions of a chromosome with different genetic variants helps to determine the benefit of these tests for specific patient groups. This article offers a bulleted list of clinical performance evaluators by which to analyze published clinical trials. Get the article here.

AI/ML: It’s Utilization in In Vitro Diagnostics

Originally Published July 5, 2023
By Sarah McLeod, M.S.

This article takes a closer look at the use of AI and ML in complying with the new IVDR requirements. Get the article here.

Leveraging Clinical Literature Reviews Across Multiple Regulatory Deliverables for the EU

Originally published July 5, 2023
By Erica Kramer, Ph. D.

This article outlines an MDR compliant, systematic literature review process. Get the article here.

Similar Devices in State of the Art

Originally Published May 4, 2023
By Priscilla S. Monarca, M.P.H.

This article defines similar devices and best practices for similar device data included in state of the art evaluations and CERs under EU regulations. Get the article here.

Best Practices for the State of the Art Evaluation

Originally Published April 20, 2023
By Priscilla S. Monarca, M.P.H.

This article outlines best practices for creating the state of the art evaluation under EU regulations. Get the article here.

The Secret to Staying Ahead of Your Competition

By Rosemarie Szostak, Ph.D., Senior Analyst, Ben Bahavar, Ph.D., Senior Analyst, Jeffery Magee, BSME, MBA, Analyst – Innovation & IP Management
Originally published August 23, 2021
This article explores the importance of a targeted approach to stay ahead of competitors, disruptive technologies, regulatory hurdles, potential customer requirements, and supply chain issues. Get the article here.

Adverse Event Reporting: Pfizer, Inc. and Moderna, Inc. vs. Johnson & Johnson

By Ryan Rix, Nerac Analyst
Originally published June 3, 2021
This article looks at how the VAERS (Vaccine Adverse Event Reporting System) tracks adverse events and post market surveillance. Read more here.

Innovations in Medical Devices – Crisis as Motivation

By Helga Weires, Nerac Analyst
Updated May 1, 2023
In the wake of the COVID-19 pandemic, the world continues to recover from disruptions in supply chain. For many manufacturers and suppliers, a shift in the business landscape depends on looking at adjacent markets, new supply chain sources and embracing new ways of thinking and manufacturing processes that maximize chances of success, not just survival. How prepared are you to weather a storm? Get the article here.

The Clinical Evaluation Plan: Creating a Storyboard for a Medical Device

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 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.