In unserem Blog finden Sie weitere Informationen zu aktuellen Themen aus der Welt des Softwaretestings, sowie technischen Details zu unseren Produkten und Dienstleistungen.
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).
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.
Performing an audit and implementing the recommendations results in improvements in the Process and reduce Risk for software development. In this blog entry we will show you some of the key questions (from our extensive questionnaire of over 200 questions) we ask your company as part of our Target Analysis.
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.
Agiles Vorgehen bei der Softwareentwicklung stellt die Software-Qualitätssicherung und Sie vor neue Herausforderungen! Durchgängige Software-Qualitätssicherung ist ein wesentlicher Baustein für den Erfolg des Softwareprojektes.
Die Testorganisation definiert die Rollen, Verantwortlichkeiten und die Organisation der Personen und Ressourcen, die am Testen eines Projekts beteiligt sind. Im folgenden Blogeintrag erfahren Sie, wie Sie eine Testorganisation richtig aufbauen.
Warum die End-to-End-Qualitätssicherung die Basis für einen reibungslosen Software-Rollout ist. Es ist ein offenes Geheimnis, dass in der modernen Geschäftswelt eine effiziente IT die Grundlage für ein erfolgreiches Unternehmen ist.
During development of medical devices, software standard IEC 62304 must be followed, and regression testing is a vital part of the Quality Assurance process.
