As the Medical Device Regulation (MDR) deadlines are approaching for re-certification and/or introduction of new products, manufacturers are also working to start or fulfil the Post-market Clinical Follow-up (PMCF) activities as per requirements set out in Annex XIV, part B of the MDR.Details
The COVID-19 pandemic has overwhelmed our healthcare delivery systems and has effected the delivery of medical care across the spectrum. Medical device companies have also been hit by the crisis
as they struggle to make decisions regarding supply chains, and regulatory obligations in the midst of uncertainty.
Please find our blog discussing the impact of the pandemic on medical device regulations.
Background Writing is a medium of human communication to express one’s thinking in easily understandable but effective way. The strength of writing is displayed by its knowledge-transforming effects. Knowledge is vital at every stage of research-based endeavours in basic research, clinical research, drug development lifecycle, drug approvals, phases of clinical trials, and post-marketing research. At…Details
It has been weeks and months since we have stopped counting days being in this pandemic-driven lockdown. There is a unique quality to this day-by-day pandemic despair; this quarantine depression is edging humans into physical and mental stagnation. According to an article I read in the Hindu couple of days back, approximately 12.2 crore Indians…Details
Good Clinical Research Practice (GCP) is an established international ethical and scientific quality standard process for the design, conduct, performance, auditing, monitoring, recording, analysis, and reporting of clinical studies. GCP ensures that the reported data and results are credible and accurate, and the rights integrity and confidentiality of study subjects are respected and protected. All…Details