3 min read
AI Medical Devices: Key Considerations for Development and Documentation
The integration of artificial intelligence into medical devices represents a transformative shift in healthcare technology. Yet, for manufacturers...
Quality
4 min read
Scope of Statistical Applications in Risk-Based Quality Management (RBQM)
Risk-based quality management (RBQM) represents a core area of clinical development that systematically focuses on both safety and data quality risks...
6 min read
Building Blocks of Quality: The Role of Design Control in Medical Device Development
Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product...
3 min read
Risk Management in Pharmacovigilance
It’s important to know that whenever a new medicinal product is authorized based on specified indications at the time of authorization, the benefits...
3 min read
Five Advantages of Veranex’s Quality Management Systems
Our approach to Quality Management ensures that we’re always speaking the same language.
4 min read
Built to Fit Your Needs: Our CDMO Capabilities
Learn about our capabilities and offerings as a CDMO We sat down with Bill Croisetiere (VP, Integrated Supply Chain), Chris Vigneau (VP,...
2 min read
Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule
On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP)...
3 min read
The Role of Scientific/Medical Literature Screening and Review in Pharmacovigilance
Why search the scientific and medical literature?
5 min read
Medical Device Vigilance: Important Considerations to Comply With the EU MDR
Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...
3 min read
Agile vs. Regulatory: How the Two Coexist and Contribute to Successful Medical Device Software Development
Software is gaining relevancy in a broad range of medical devices, as it either enables the control or influence of their operation, or because...