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Supply Chain Risk: How to Identify and Manage Liability
In today's highly competitive marketplace, healthcare organizations and medical device manufacturers need to prioritize supply chain risk management to avoid costly...
Demystifying Failure Mode and Effects Analyses (FMEAs) in Medical Device Manufacturing
Failure Mode and Effects Analysis (FMEA) is a design review tool used to identify and correct all possible failures in a product, service, design or manufacturing...
What Does the Implementation of EU-MDR Mean?
The passing of the EU Medical Device Regulations (EU-MDR) is forcing medical device manufacturers to update their clinical testing practices and reporting mechanisms....
The Evolution of US Medical Device Regulation
Medical devices are regulated according to the same legislation as food and pharmaceuticals, under the general organization of the Food and Drug Administration (FDA)....
ASTM Standards and Testing of Flexible Materials Used in Healthcare
The ASTM (formerly the American Society for Testing Materials, currently ASTM International) is an organization that develops and publishes consensus technical standards...
Regulatory Overview of Leachables and Extractables in Flexible Medical Devices
Many factors affect the safety, suitability, and efficacy of the various medical devices used every day in the healthcare setting. Flexible medical devices are utilized...
Identifying & Understanding the 8 Wastes
When considering potential waste in a medical manufacturing facility, most precision manufacturer’s first thoughts are only on the material waste. In fact, there are 8...
The FDA Regulatory Pathway for Premarket Notification 510(k)
The FDA regulatory pathway for Premarket Notification 510(k) is required by anyone who intends to market a Class I, II, or III device in the United States intended for...
Successfully Implementing a CAPA Process
The framework of corrective and preventive action (CAPA) can be intimidating to tackle; especially if you are in a new organization or one that does not already have an...