Blog
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.
Why Do We Need Risk Management for Medical Devices: How Risk Management Can Add Value and Reduce Risk
Discover why risk management for medical devices is essential for device manufacturers. Learn how it adds value, enhances safety, and reduces risk. Explore practical strategies and real-world applications with insights from Fission Consulting.
Email Marketing for SaMD: Tactics to Engage Healthcare Professionals and Decision-Makers
Discover the best practices for email marketing tailored for SaMD companies. Learn how to engage healthcare professionals, ensure compliance, and optimize your campaigns for maximum impact. Read our comprehensive guide now!
How to Validate a Medical Device Idea: From Concept to Market-Ready Device
Learn how to validate a medical device idea from concept to market-ready product. Discover essential steps, best practices, and expert insights to ensure your innovation meets regulatory standards and user needs.
Implementing DevSecOps for SaMD: Best Practices for Securing Patient Data and Devices
Learn how to enhance the security of Software as a Medical Device (SaMD) with our comprehensive guide to DevSecOps for SaMD. Discover the core principles, integration strategies, and essential tools for securing patient data and devices throughout the software development lifecycle.