The commercialization of medical devices and drugs depends on a single aspect – patient safety. Patients must know that the device or drug does what it is supposed to do and won’t unintentionally harm them. Enter, quality management. Quality manageme...
A week of intensive United States Food and Drug Administration (FDA) inspection has just concluded for your team, and while there’s a cautious sense of relief, there’s still that persistent concern.
The right electronic Quality Management System (eQMS) can help strengthen your compliance processes and build a culture of quality within your organization. Discover the eight best quality management software and learn how to choose the right one for...
The modern medical life science industry is a multiple-wheeled machine. It takes a lot of groups working in tandem to get a medical product on the market. While the majority of the production and assembling might happen in the manufacturing facilitie...
As the life sciences industry becomes increasingly regulated and competitive, quality management has become more vital than ever. Are you confident in your organization’s Quality Management Maturity (QMM)?
Software as a Medical Device (SaMD) is a groundbreaking advancement in the healthcare industry, transforming the way medical care is delivered and managed. First developed in its earliest forms in the 1980s, this category of software operates indepen...
In life sciences, especially if you’re in the medical device industry it becomes harder to manage projects in accordance with your company’s quality management system. Companies design and/or develop products every day to improve their existing produ...
On November 25, 2020, the European Commission adopted the pharmaceutical strategy for Europe, an initiative that aims to transform the pharmaceutical landscape in the European Union.
Developing medical products is no easy feat. Most of these products are highly quality-sensitive and expensive. Naturally, most companies want to work with the best experts in the field, as there is little room for error. Consulting firms have steppe...
Introduction Despite its crucial role in life sciences, college curricula often overlook technical writing. However, life sciences professionals are expected to possess this skill and demonstrate it at a level that frequently exceeds their capabiliti...
How to get your management team to say “Yes” to an eQMS As a quality professional, you know the value of an eQMS. You’re aware of the drawbacks of manual or paper-based systems and how an eQMS can enhance speed, safety, and efficiency in your organiz...
In the pharmaceutical and medical device industry, manufacturers must make sure medicines and healthcare products are made correctly, stored safely, and delivered to the people who need them. Supply chain management is the planning and organizing tha...
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