Swissmedic, the Swiss Agency for Therapeutic Products, is involved in the entire life cycle of a medicinal products because of its mandated areas of responsibility in the sectors of licensing and the authorisation and monitoring of medicinal products. It is involved in the legal aspects of the process.
The quality and reliability of Bluetooth enabled devices is important and testing manually is time consuming, prone to errors and expensive. Automation of Bluetooth testing improves quality and reliability, while reducing costs. The Bluetooth Testing Framework supports the automation of testing Bluetooth enabled devices.
Across industries, standards are an important way to safeguard product conformity while simultaneously harmonizing requirements both nationally and internationally. Quality assurance is vital to ensure that the producer correctly applies standards.
GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. Good Automated Manufacturing Practice (GAMP 5 ®) sets out principles and procedures that help ensure that pharmaceutical or medical device products have the required quality and details a recognized standard for Computer system validation (CSV).
Discover the impact of Artificial Intelligence (AI) on Testautomation in software development. Read our latest article on meinTest.software to learn how AI is changing the way software is tested and how SmartBear's TestComplete is providing an innovative solution to improve the quality and speed of software testing. Find out how AI-supported tools are detecting errors early on and saving time for test engineers.
Companies can really benefit from implementing an independent QA audit based on TMMI, CMMI and itsbusiness AG have more than 20 years’ experience in different industries. Performing an audit and implementing the recommendations will result in improvements in the Process and reduce Risk for software development.
Are you looking to save on costs, while improving the software quality of your comms enabled medical/sensor/drone device? If yes, then see how this can be done in our blog post on Hardware-in-the-Loop Testing.
In the pharmaceutical industry, good practices are an important way to safeguard product conformity and safety. Quality assurance is vital to ensure that the producer correctly applies good practices.
Standards are the vital keystone upon which safely functioning medical devices are built. Across industries, standards are an important way to safeguard product conformity. Standards harmonize requirements both nationally and internationally. Our whitepaper covers the Standards applied to the development of Software for Medical Devices. It highlights the most important points for Software Quality.
Usability is a key component of safety for medical device usage, and a clear and understandable user interface is vital. The standard which covers this is IEC 62366.
ISO standard ISO 14971 is used for the application of risk management to medical devices. This standard was developed specifically for manufacturers of medical devices on the basis of established principles of risk management that have evolved over many years.
Across industries, standards are an important way to safeguard product conformity while simultaneously harmonizing requirements both nationally and internationally. Quality assurance is vital to ensure that the producer correctly applies standards.
In the pharmaceutical industry, good practices are an important way to safeguard product conformity and safety. Quality assurance is vital to ensure that the producer correctly applies good practices.
Are you concerned about ensuring the stability of your Bluetooth-enabled device? If so, check out our latest blog entry on how our Bluetooth Testing Framework can help you automate testing and produce more reliable Bluetooth-enabled devices.
During development of medical devices, software standard IEC 62304 must be followed, and regression testing is a vital part of the Quality Assurance process.
Medical devices and associated software are heavily regulated. The international standard IEC 62304– medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices.
