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...
Product Development (3)
1 min read
Playing Defense: Cybersecurity for Diagnostic Devices
No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments...
3 min read
Expert Insights: Project Management with Matt Perry
Recently we sat down with Matt Perry, VP of program management at Veranex, to talk about common project management issues within medtech, and his...
2 min read
Ensuring Compliance with New FDA Guidance on Software Documentation & Cybersecurity
New guidance from the FDA replaces similar, but now obsolete, guidance. Some of the guidance was issued in response to the PATCH Act, which is a 2022...
2 min read
Clinical Utility Evidence Planning: Framework, Assessment Techniques, and Case Study for a Diagnostic Test
Clinical utility describes the usefulness of a medical product (device, diagnostic/prognostic, or therapeutic) for physicians and/or patients, and...
2 min read
Avoid These Four Medical Device Supply Chain Woes
Anyone who works in medtech product development knows that surprises are a guarantee. That’s why it’s important to create stability and...
5 min read
The Promise of Pulsed Field Ablation and the Critical Role of Preclinical Science in its Advancement
Atrial fibrillation remains a leading cause of death and disability and the most common type of arrhythmia. While radiofrequency ablation and...
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.
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)...
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...