Blog
The Top 8 Threats and Challenges of AI in SaMD
Explore the transformative role of AI in SaMD. Discover the opportunities Artificial Intelligence presents, from enhanced diagnostics to personalized treatment plans, and learn about the key threats and challenges for consideration and successful implementation.
Lean Product Development for Medical Devices: Accelerating Innovation and Reducing Costs
Discover how lean product development can streamline the process for medical devices, reducing waste and accelerating time-to-market. Learn key strategies and actionable steps to implement lean product development for medical devices.
Top 5 Common Pitfalls in FDA Pre-Submission Meetings and How to Avoid Them
Learn about the common pitfalls in FDA pre-submission meetings and discover strategies to avoid them. Ensure successful regulatory interactions for your medical device startup with our expert tips.
11 Core Elements of a Quality Management System (QMS) Explained
Discover the 11 core elements of a Quality Management System (QMS) and learn how each component guides your organization towards quality excellence and regulatory compliance.
Quality Assurance vs Quality Control in Medical Devices: Understanding the Key Differences
Discover the critical differences between Quality Assurance vs Quality Control in medical devices. Learn how these processes ensure product reliability, regulatory compliance, and patient safety, and find out how Fission Consulting can help you implement effective quality management strategies.
Choosing the Right Path: 510(k) vs De Novo Pathways for SaMD
Discover the key differences between the 510(k) vs De Novo pathways for SaMD (software as a medical device). Learn how to choose the right regulatory path to bring your innovative medical software to market quickly and efficiently.