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…
Product Development – API & Formulations
Overview - The terms used in drug formulations and active medicinal ingredients are widespread in the pharmaceutical business. It is a constant challenge for pharmaceutical corporations to develop new patent…
Computer System Validation in Pharma
In the fast-paced and highly regulated world of pharmaceuticals, computerized systems are integral to various processes, from research and development to manufacturing and distribution. Ensuring the efficacy, safety, and quality…
A Comprehensive Guide to Design Qualification in Pharma and Biotech Facilities
INTRODUCTION - Design Qualification includes all facets of facility and equipment design and acquisition. It is meant to have everything that could happen during the design, development, and checkout phases,…
Key Qualities for Regulatory and Quality Consultants
Regulatory consultants and medical device consultancies are groups of highly skilled healthcare industry experts. The medical device sector is developing ever-more-advanced equipment with the swift advancement of medical knowledge. However,…
