Objective:
Our client approached us with a Clinical Evaluation Report (CER) assignment for a Class IIa medical device. We were required to prepare end-to-end document; however, the literature search strategy was prepared at the client end based on the search terms provided by us.
The 21st century has witnessed a breakthrough in the field of healthcare. Technology in healthcare has taken a giant leap since the invention of computers. Not only for industrial purpose but even for our daily activities, our dependence on artificial intelligence (AI) is on an uphill ride¹. Mobile medical apps are now an integral part…
The term ‘pharmacovigilance’ was coined in the mid 70’s by a group of French pharmacologists and toxicologists to describe the operations encouraging evaluation of the risks and side effects potentially associated with drug treatment.(1, 2)The World Health Organization (WHO) defines pharmacovigilance as, ‘the science and activities relating to the detection, assessment, understanding and prevention of…
The In Vitro medical devices faced the implementation of the European Community Directive 98/79/EC in 1998. The In Vitro Diagnostic Directive (IVDD) 98/79/EC has been now transformed to In Vitro Diagnostic Regulation (IVDR) 2017/746/EU. The official timeline for this transition phase to complete implementation is 5 years (26th May 2022). The current regulatory framework for…
This whitepaper aims to guide students and professionals and provide them with updates regarding Plan S, Open Access, cOAlition S. Plan S, launched by Science Europe in September 2018, has been gaining significance as it is seen to be a milestone in progression towards universal access to recent research findings. Plan S is an allied…
Most of us have possibly used it or sprinkled on our skin at some point in our life, ‘Talc’ which is a processed from of soft mineral compound of magnesium silicate and is called talcum powder or just talc in general terms. The natural smoothness and adsorbency of talc have been utilized since millennia and…
The European Economic Area (EEA), inclusive of the European Union (EU) and European Free Trade Association (EFTA), has been contemplated as one of the largest global medical device markets. The obvious aspiration for device manufacturers is gaining an approval and maintaining access to this important market. It requires abiding by the regulatory changes to assure…
Women Innovation and Entrepreneurship Foundation (WIFE) had conducted the second edition of the National Leadership Summit on Women and Education on 18th Feb 2019 at Vigyan Bhawan, New Delhi. The Chief Guest of the summit, Shri Suresh Prabhu, Honorable Minister of Commerce, Industry and Civil Aviation addressed the gathering and acknowledged women and men who…
Turacoz Healthcare Solutions propitiously organized training on Medical Writing and Pharmacovigilance at Springer Nature, Pune on 24th-25th September 2018. Dr. Namrata Singh, Director and Vasudha, Lead Medical Writer of Turacoz Healthcare Solutions were the facilitators of the workshop. The sessions zeroed in on types of publications, lifecycle of a manuscript, literature search, safety narratives, aggregate…
