Appraising and evaluating the search results In our previous blog, we focused on performing a successful database search and doing the first screening of search results through titles and abstracts. In this final, third part of our three-part series, we …
Performing a database search and an initial analysis of the search results In our previous blog we focused on understanding the goal of our literature search and on writing a good, solid literature search and review protocol. In this second …
FROM SETTING THE GOAL TO THE LITERATURE SEARCH AND REVIEW PROTOCOL In the forthcoming three part blog series, we would like to shed more light on the Literature Review process in accordance with the Medical Device Regulation (MDR). In today’s …
We are delighted to welcome Jelena, our new full-time employee. Jelena has unique expertise combining extensive working experience as a Legal Analyst and a Scientific Literature Librarian. Jelena will work on writing literature protocols and reports for the MDR Clinical …
AUTHOR Daniel Albahari, CEO & Principal Regulatory Consultant, BioReg Services, Israel. KEYWORDS EU Medical Device Regulation; MDR; MedTech; Non-medical devices; Annex XVI; Clinical evaluation; Post-market surveillance; Risk management. ABSTRACT In this article, we explore a newly introduced product category described …
As you know, placing a new medical device on the market is the end result of long and laborious team work. A medical device team can vary depending on the product type but it will almost always, without exception, include …
As manufacturers of medical devices and sponsors struggle to meet MDR conformity, a second MDR amendment published at the end of 2019 may benefit some EU device manufacturers. In this blog we want to summarize what the MDR grace period …
We think it could. Final guidance for FDA “Breakthrough Devices Program” was published in December 2018. As this could be potentially relevant for many medical devices in development, we thought it would be worthwhile bringing it to your attention. Ultimately, …
The purpose of this blog is to provide initial info about certain regulatory pathway options, or the lack of these, for products containing cannabis or for cannabis derived compounds in the United States and European Union. The reader should bear …
Clinical evaluation represents a methodologically sound ongoing procedure to collect, evaluate and examine the clinical data relevant to a medical device. As the application date for the new Medical Device Regulation MDR approaches, many clients have turned to us to …