In today's highly competitive marketplace, healthcare organizations and medical device manufacturers need to prioritize supply chain risk management to avoid costly...
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...
The passing of the EU Medical Device Regulations (EU-MDR) is forcing medical device manufacturers to update their clinical testing practices and reporting mechanisms....
Medical devices are regulated according to the same legislation as food and pharmaceuticals, under the general organization of the Food and Drug Administration (FDA)....
The ASTM (formerly the American Society for Testing Materials, currently ASTM International) is an organization that develops and publishes consensus technical standards...
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...
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) is required by anyone who intends to market a Class I, II, or III device in the United States intended for...
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...