Blog
ISO 13485 vs FDA QMSR: Breaking Down the Key Changes in User Needs Documentation
Discover the key differences in user needs documentation between ISO 13485 vs FDA QMSR. Learn what’s changing, what stays the same, and how to stay compliant.
How Fission’s Software Makes Audit-Ready Compliance Effortless
Discover how Fission’s QMS redefines audit-ready compliance software with a data-first, always-on approach. Say goodbye to last-minute audit prep and hello to effortless, continuous compliance.
Top 5 SaMD Development Challenges and How to Solve Them
Developing Software as a Medical Device (SaMD) comes with unique challenges, from regulatory hurdles to cybersecurity risks. Learn the top 5 SaMD development challenges and how modern tools can streamline compliance, testing, and security to accelerate innovation.
ISO 13485 and Customer Satisfaction for Medical Device Companies
Discover how ISO 13485 and customer satisfaction are connected. Learn how medical device companies can boost customer happiness by aligning with ISO 13485 standards.
Navigating IEC 60601 Compliance for Medical Devices: A Practical Guide
Learn how to achieve IEC 60601 compliance for medical devices. Discover practical strategies to streamline compliance, integrate it into your quality management system, and bring safer products to market faster.
Medical Device Risk Management Simplified: Our Top 5 Practical Tips for Compliance
Discover practical tips for simplifying medical device risk management. Learn actionable strategies for aligning with compliance standards, whether developing traditional devices or SaMD.