Equivalence Demonstration of medical device
A typical path to MDD compliance was claiming medical device equivalency, which spared businesses the time and expense of producing fresh clinical data. But since the EU MDR came into…
FDA submission types for medical devices
Introduction - The FDA may receive several submissions about newly developed or altered medical devices being marketed in the United States. The two most popular forms of market authorization submissions…
How ND Global Hires Nurse practitioner in the US
Introduction - A nurse practitioner, also known as an advanced practice nurse, is a medical community member who has completed additional coursework in a university setting to acquire advanced skills…
ROOT CAUSE ANALYSIS
INTRODUCTION: A crucial component of CAPA procedures in the pharmaceutical sector is root cause analysis (RCA). The goal of root cause analysis (RCA), a methodical technique used to research, is…
ISO 13485 vs. CFR Part 820
Introduction - Manufacturers of medical devices are subject to regulations worldwide to protect the consistency of their products. Manufacturers require a well-organized quality management system to do this. It is…
510 (k) VS PMA: Major differences
Introduction - The FDA typically requires you to complete a 510k submission or seek premarket approval for your medical device if you intend to manufacture or distribute it within the…
Types of 510(k) Overview
Introduction - The Food and Drug Administration (FDA) guarantees the efficacy and safety of medications, biologics, and medical devices. The FDA's medical device regulatory procedure is a significant obstacle to…
Introduction to 510 (k) Submission
Introduction - An FDA premarket submission is called a 510(k). Because it alludes to that particular portion of the Food, Drug, and Cosmetic Act, it is known as a 510(k).…
Clinical Evaluation Report (CER)
Introduction - A medical device's safety and assessment report is called a Clinical Evaluation Report (CER). It is based on clinical data from various device research and clinical investigations. A…
Analytical Method Validation in Pharmaceutical Quality Assurance
Introduction - An applied strategy to confirm that a procedure is appropriate to serve as a tool for quality control is called validation. Any analytical measurement's intent is to produce…
