Additional Content
2020 Ultimate Guide to Connected Quality Data
Visualizing a new data-centered quality paradigm. When the first Nokia and Motorola cell phones that were affordable and small enough to fit in your pocket hit the market...
Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers
WD-40 Company Case Study
WD-40 Company needed a way to ensure that every drop of product produced by globally diverse contract manufacturing organizations (CMOs) measured up to the company’s unwavering standard of quality.
2:50Cochlear Helps People Hear with the Help of MasterControl
Cochlear helps people hear and be heard by providing high-quality devices. They use MasterControl to ensure quality across the organization.
Hu-Friedy
Read how MasterControl helped Hu-Friedy ensure compliance with FDA's 21 CFR Part 820 Quality System Regulation (QSR), and ISO 13485.
EU MDR: How to Prepare for the Upcoming Changes in Regulation
The Medical Devices Regulation and In Vitro Dianostic Regulation deadlines are fast approaching. Learn the requirements, timelines, and terminology you need to be prepared.
Top Device History Record Pain Points
Device history records (DHRs) are the most important artifacts generated in the course of medical device manufacturing, yet many manufacturers still rely on manual, paper-based DHR systems.
The Evolution of Medical Device Clinical Trials: Their Background and a Look Toward the Future
Knowledge of regulatory requirements and the application of rigorous clinical investigation processes can help companies accelerate the time it takes to bring new devices to the market.
How to Address the Top 6 Pains in DHF Management
Noncompliance among medical device developers typically falls under two areas: design control and document management. These two critical elements intersect in one place: the design history file.
ISO 13485 - Change? Do I Have To??
Review the conundrum companies are experiencing if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system.
How Medical Device Firms Can Thrive Despite Tax Uncertainty
The medical device landscape is changing, due in large part to the controversial U.S. excise tax that applies to American-made and imported medical devices.
cGMP and ISO 13485 Integrated Quality Management System
The Food and Drug Administration (FDA) has established and maintains Part 820- Quality System Regulation (QSR), also known as 21 CFR 820 or 'Current good manufacturing practice' (cGMP).
Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview
Examine how obtaining ISO 13485 certification can open doors to untapped domestic and international business opportunities, and obtain recertification to the new revision.
The Value of Studying and Utilizing FDA's QSIT Manual
The FDA’s approach to the inspection process of medical device manufacturers, Quality System Inspection Technique (QSIT), embraces a top-down inspection of a firm’s QMS.
Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?
When a company’s product development engineers and quality professionals fail to cooperate adequately, the company risks experiencing costly delays and inefficiencies.
Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments
How an enterprise quality management system (EQMS) can help you avoid 483 observations during your next facility audit.
MasterControl eDHR™ Toolkit for Medical Device Firms
Address the challenges most medical device manufacturers experience during the device history record (DHR) process when they aren’t properly leveraging an electronic DHR (eDHR) system.