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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...
Regulatory
6 min read
Navigating FDA’s Latest Guidance Updates for AI-Enabled Medical Devices: A Marketing Submission Guide
As artificial intelligence transforms healthcare innovation, the FDA continues to evolve its regulatory framework for AI-enabled device software...
4 min read
Optimizing PLM-OEM Collaborations: Key Strategies for a Smooth IVDR Transition
Under Directive 98/69/EC (IVDD), it was common practice for in vitro diagnostic medical devices to be placed on the European market under contractual...
4 min read
2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European...
2 min read
Prioritizing Patient Safety and Fostering Innovation with the MHRAs New Roadmap for Medical Devices
On January 9, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) released a regulatory framework – Roadmap towards...
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Key Insights from NMPA Guidance Draft 01 & 02 from Our Human Factors Team
The human factors team at Veranex has reviewed the NMPA Guidance Draft 01 and Draft 02 and submitted feedback to the agency. We’re committed to...
5 min read
Biocompatibility of Medical Devices: Process, Detailed Steps and 7 Hot Topics to Crack the Code of Medical Device Safety
The landscape of modern healthcare has been completely transformed by the development of cutting-edge medical devices. From life-saving implants to...
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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...
2 min read
Basics of Drug Safety: Importance of Case Processing in Pharmacovigilance (PV)
Case processing in pharmacovigilance is a fundamental activity to support safety surveillance in clinical trials. Along with an anticipated...