Author: Reshat

Two Major Challenges In Clinical Evaluation What is clinical evaluation? Clinical evaluation is a set of ongoing procedures that use scientifically sound methods to assess and analyze clinical data to verify the... Read More

Medical Device Registration Process for An X-Ray Machine Manufacturer in India. What is an x-ray machine? An x-ray machine sends individual x-ray waves through the body. The images are recorded on a... Read More

Oncology Medical Devices Manufacturing and Regulatory Compliance Oncology Devices and Diagnostics include a range of medical devices, in vitro diagnostics, and combination device products that assist patients and providers in screening,... Read More

Things You Should Know About Glucometer And Regulatory Compliance Blood Glucose Meter A blood glucose meter is a small, portable machine used to measure how much glucose (a type of sugar)... Read More

Aesthetic Medical Devices and Regulatory Compliance Learn about Aesthetic Medical Devices and Regulatory Compliance As per USFDA, Aesthetic devices are typically used to improve appearance. They may be regulated by FDA... Read More

Drug-device combination Products can be single products comprised of several components – e.g. transdermal patches, drug-eluting stents – separate products packaged together – e.g. syrup with a spoon – or... Read More

Drug-device combination Products can be single products comprised of several components – e.g. transdermal patches, drug-eluting stents – separate products packaged together – e.g. syrup with a spoon – or... Read More

Quality and Regulatory Affairs Of Medical Devices is Nothing But the regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring... Read More

Quality and Regulatory Affairs Of Medical Devices is Nothing But the regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and... Read More

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, Abbreviated. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs... Read More