Author: Reshat

UKCA Vs CE: How New Regulations Affected The Manufacturing Of Medical Devices CE Marking CE marking is a type of self-declaration in which an organization or manufacturer declares their conformity with the... 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

The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included in marketing submissions for medical devices. FDA... 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

Challenges and Opportunities with IVD Industries In Vitro – Diagnostic medical devices can help detect, treat or prevent diseases, conditions, and infections. They are mainly used to collect the samples such... Read More

Legacy Medical Devices Under the IVDR, a legacy device is a medical device: that has not undergone a conformity assessment procedure under the IVDR but. for which conformity was (or... Read More

Drug-Device Combination Products 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... 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

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