The medical device industry is no exception. Initially, software was used to drive hardware devices. But it didn’t take long before people began designing software solutions without any direct relationship to hardware devices at all. These products, while nothing like traditional Medical Device Content, still have the potential to improve the quality of life for patients everywhere.
Here are Most Popular Medical Device Content;
Ultimate Guide to Software as a Medical Device (SaMD)
Everything a manufacturer needs to know in order to establish software as a medical device (SaMD), such as how the industry is regulated and what to expect from the development process.
Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR
This article provides an explanation of what a PSUR is, how it varies from a PMS, and what components a PSUR ought to include in order to be in accordance with the requirements.
Everything You Need to Know About Root Cause Analysis
A few examples of quality events are the CAPA process, the complaint procedure, and the nonconformance procedure, among others. Find out what strategies to use, as well as the best way to put them into action.
Ultimate Guide to UDI for Medical Devices
This UDI (Unique Device Identification) guide includes all there is to know about the standard, and it was designed with manufacturers of medical equipment in mind particularly.
What is the Best Way to Structure a Risk Management File?
When it comes to Medical Device Content, the risk management files serve as the overarching record for any and all measures made to reduce risk. Is there a better way to maintain track of these records, or is this the best option?
Ultimate Guide to Device Class Requirements under EU MDR
With the help of our EU MDR Class Requirements Guide, you will be able to correctly classify and categorize your Medical Device Content in conformity with European legislation.
QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies
In order to bring its Quality System Regulation (QSR) into line with ISO 13485:2016, the FDA has suggested a new regulation known as the Quality Management System Regulation (QMSR).
Ultimate Guide to Clinical Evaluation of a Medical Device in the EU
EU Clinical Evaluation Essentials: A Comprehensive Guide for Manufacturers (EU).
Understanding the Quality Control Process in Medical Device Manufacturing
This article provides an explanation of quality control techniques used in the Medical Device Content industry, along with specific measures that businesses may take to evaluate and improve their own quality control procedures.
Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities
The Post-Market Clinical Follow-Up, often known as PMCF, is a crucial component of the post-market monitoring operations you do. Find out more about how to prepare and carry out your PMCF by reading the information here.