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.
Digital Transformation – How to Do it Right
Originally Published April 18, 2023
By Dr. Ripi Singh, Dr. Johannes Vrana, Inspiring Next
A large fraction of Digital Transformation efforts fail to deliver their promised value. This article helps to demystify Digital Transformation and build an executable roadmap. 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.
What was Old is New Again: Chemical Recycling of Plastic Waste using Pyrolysis
Originally published February 3, 2023
By Ben Bahavar, Ph.D., Richard Maldanis, Ph.D., Rosemarie Szostak, Ph.D.
This article takes a closer look at the advancements in chemical recycling, patent activity and the supply chain impacts of this emerging technology. get the article here.
Get a Grip….Get a Gecko!
Originally published January 25, 2023
By Rosemarie Szostak, Ph.D.
This article explores biomimetic and gecko-inspired technologies, and thier potential commercial applications. Access 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.
Recession: The Mother of All Innovation
Originally published November 3, 2022
By Jeffrey Magee, BSME, MBA, Nerac Analyst-Innovation & IP Management
This article provides evidence-based examples of how a patent landscape can help to guide technology development, patenting, and freedom-to-operate (FTO) strategy.
Get the article here.
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