The number of software - mobile applications intended for use in the field of people's health and well-being is constantly increasing. The aim of this review is to compare regulations on software - mobile applications as medical devices in the United States of America (USA), European Union (...
Chambers USA 2024 "Latham is highly strategic and laser-focused on getting the best business result for the client." Chambers USA 2024 Tier 1 – Life Sciences The Legal 500 US 2024 "Renowned for its healthcare and FDA regulatory practice, which is working alongside government bodies to develop...
Regulatory Affairs profession was developed by the government regulatory bodies to regulate the safety and efficacy of products to protect the health of public. This was developed in all most all divisions of health care industry likepharmaceuticals,veterinary medicines,medical devices,pesticides, agrochemi...
In Mexico leading cancer is colorectal but only have the FIT test and noone except one organization who issupplying health access Access to precision medicine is a concern: the communication between the patient, who is pushing this more than healthcare, needs to be coordinated better with all st...
Medical Device is an essential component of our healthcare industry where it's utilized to save lives. That is why ensuring their safety is a top priority. Patients expect devices used on them to be able to improve their quality of life because of which proving their regulatory compliance ...
Your experience in the registration of products in the USA, and EU (other markets desirable) and your excellent technical writing experience within a medical device environment will help make you very successful. It would also be an advantage if you have knowledge of software as a medical device...
“If these tests become more widespread,” the IOM noted, “it is doubtful that there will be enough health care professionals prepared to provide even the most basic counselling required to assist patient understanding” (National Academy of Sciences, Institute of Medicine, 1990). The IOM did ...
The diversity of regulatory standards originates from differences in healthcare systems, cultural nuances, and socioeconomic variables. Navigating a myriad of regulations is a challenging task. This makes the approval and marketing of important and lifesaving treatments very complex. Stumbling around in...
Both recombinant histidine-tagged FUBP3 and PCBP2 proteins were purified by the HisTrap column (GE healthcare), according to manufacturer’s instructions. The GST protein was purified by the GST affinity beads (Elpis Biotech) to be used as a control protein. The purified recombinant proteins ...
One of the most common types of tests for identifying and understanding microbial pathogens in healthcare is the nucleic acid amplification test (NAAT). Accuracy and reliability of such tests is, in some cases, a matter of life and death for both patients and laboratory professionals. It is a...