Medical Device & Healthcare

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 Road to IVDR Implementation

Originally Published March 20, 2023
By Sarah McLeod, M.S.

Dramatic changes to the regulatory landscape for in vitro diagnostic (IVD) medical devices are in the making. This article takes a closer look at the revised implementation timeline and potential impacts on certification. Get the article here.

EU MDR CER Literature Review Process: Expectations and Best Practices

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.

Medical Device Claims and Clinical Evaluation Under the EU MDR

Originally published February 13, 2023
By Miriam Sharif-Murray, M.S.

A closer look at the requirements for medical device claims and how they impact the clinical evaluation process, subsequent Clinical Evaluation Report and eventual conformity to medical device regulations. Get the article here.

The Use of Published Literature in FDA Medical Device Submissions

Originally Published January 13, 2023
By Miriam Sharif Murray, M.S.

This article explores the different types of published literature that can support Class III Medical Device submissions for FDA compliance. 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.

The European In Vitro Diagnostic Regulation: Performance Evaluation

By Erica Kramer, Ph.D., Senior Nerac Analyst/Medical Writer
Originally published June 30, 2020
This article explores clinical evidence, performance evaluation and the resulting challenges to manufacturers, and offers guidance on how to navigate them with success. 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.