With the up-classification of medical devices as per the new EU MDR, software used as a medical device has been affected the most. Under Rule 11: “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes...
Nonconforming products happen but managing them before they spin out of control is important. With QualiPro you can manage non-conforming products with ease. It easily tracks products through all phases of the nonconformance process: description, analysis, investigation, decision, closure, and...
Having a good CAPA management system is a key element in making sure your CAPA process is successful. QualiPro has the functionality to manage the entire CAPA process – even those CAPAs that originate in other systems. A request can be...
After the shutdown of a major contract sterilization facility in Illinois, and another one in line to close its doors soon, FDA is worried about a shortage of medical devices. Ethylene Oxide is a widely used sterilization technique for medical products...
CAPAs are often the most dreaded task to complete and the words “open a CAPA” can bring audible sighs and groans, but CAPAs are an important tool in improving the quality of products and processes. A good CAPA system can...
FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, subject to special controls and pre-market notification. Currently, both internal and external surgical staplers are classified as class I, subject to...
Ensuring you have a robust Quality Management System (QMS) is the first step in maintaining compliance with both FDA and ISO regulations and requirements. A good software-based quality management system can make the process much easier. A paper-based or multi-software...
With the increasing use of software in every medical device, it is very important for every manufacturer to know how to correctly fit the software into their design control requirements outlined in 21CFR 820.30. If you have software as part of...
Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in the production of the device or in implementation of the device manufacturer's quality system. Any medical...