RQM+ Medical Device and In Vitro Diagnostic Blog

on 9 December 2024 | By Jaishankar Kutty, Ph.D., RQM+ Vice President, Global Regulatory Affairs

Executive Summary Tricuspid regurgitation (TR), historically overshadowed by left-sided valvular diseases, is increasingly recognized as a significant contributor to heart failure (HF) symptoms, hospitalizations, and mortality. Despite its prevalence, TR often remains...

on 2 December 2024 | By Jaishankar Kutty, Ph.D., RQM+ Vice President, Global Regulatory Affairs

Introduction: The (Not So) Forgotten Tricuspid Valve Tricuspid regurgitation (TR), historically overshadowed by left-sided valvular diseases, is increasingly recognized as a significant contributor to heart failure (HF) symptoms, hospitalizations, and mortality. Despite its...

on 26 November 2024 | By Dr Dr Cordula M Stover, Senior Medical Writer, RQM+

A clinical study design describes the methodology with which to pursue the aims and objectives of a clinically important research question in a target population.

on 15 November 2024 | By Jaishankar Kutty, Ph.D., RQM+ Vice President, Global Regulatory Affairs

Heart failure with reduced ejection fraction (HFrEF) is a progressive condition affecting millions worldwide, imposing both a clinical and economic burden on patients and healthcare systems. While guideline-directed medical therapy (GDMT) remains the cornerstone of treatment,...

on 14 November 2024 | By Dr Dr Cordula M Stover, Senior Medical Writer, RQM+

The purpose of clinical studies is to scientifically address an unmet clinical or regulatory need in the treatment of patients. Informing clinical practice and policy, the outcomes ultimately aim to improve health care. Working in a client centric manner, RQM+ helps navigate...

on 17 June 2016 | By Kate Keverline

Everyone appreciates a good night's sleep. A big obstacle to that is the fact that 18 million American adults suffer from Obstructive Sleep Apnea (OSA), and the condition arises simply from a wayward throat muscle. A new study by Dr. Richard Schwab, co-medical director of the...

on 18 February 2016 | By Stephen Biernacki

About R&Q's Case Studies: We hope you enjoy our third case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available. Challenge High volume of data... and differing opinions. A client's product is...

on 18 October 2013 | By Ryan Kasun

The standard treatment for patients with cancer of the larynx is to have a tracheostomy tube installed. Tracheostomy tubes are Class II devices, under 21 CFR 868.5800. According to ProTip CEO Maurice Beranger, this technology has not changed in 140 years. Tracheostomy tubes...

on 25 October 2012 | By Ryan Kasun

October is a very important month for women: It’s National Breast Cancer Awareness Month. There are many things to be proud of for how far we have come with treating breast cancer. The Susan G. Komen Foundation reports that the 5-year survival rate for female breast cancer...