What is a Unique Device Identifier (UDI)?
Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to:
Unambiguously identify a device for patient safety
Improve medical device traceability in the supply chains
The Unique …
Faecal microbiota transplants are quickly gaining popularity around the world. If you have heard of FMT, chances are either you are not particularly squeamish or you have had enough time to digest the concept, pun intended. To put it …
How is the pharmaceutical manufacturing industry around the world expected to continue production during the COVID-19 pandemic? What control measures should be in place to help prevent or mitigate the potential adverse effects of COVID-19 on the safety and …
Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for medical device manufacturers and importers. …
Electronic Quality Management Systems (eQMS) have gained increasing popularity within the healthcare industry over the last decade. The following diagram shows the various processes for which management, communication and workflows can be automated via the use of an eQMS
Often, companies find themselves inundated with open CAPAs. This is most commonly experienced in the aftermath of an audit, where the CAPA system is used to document the issues that are identified, the investigations, the execution of corrective and/or preventative actions, and finally the closures.
