Blog
The Role of Biocompatibility in Medical Device Design (ISO 10993)
Discover the crucial role of biocompatibility in medical device design. Learn how ISO 10993 standards impact safety, design decisions, and compliance. Explore key testing methods and best practices for integrating biocompatibility into your product development process.
Is Your Quality Management System Ready for the February 2026 QMSR Deadline?
The new QMSR deadline is coming fast—find out what your medical device company needs to do to meet the February 2026 deadline. Get actionable tips on how to prepare your Quality Management System now.
The Best SaaS Tools for Medical Device Startups in 2025
Discover the top SaaS tools for medical device startups in 2025 to streamline compliance, boost efficiency, and scale your business. Learn what tools to prioritize and how to choose the right ones for your needs.
What Does the FDA’s QMSR and ISO 13485 Alignment Mean for Medical Device Companies?
Learn how the FDA’s QMSR and ISO 13485 alignment impacts medical device companies. Explore key changes, why they matter, and how to prepare for compliance.
Understanding IEC 62366 for Medical Devices: Designing for Usability
Learn how IEC 62366 for medical devices helps companies ensure usability and patient safety. Discover the key principles, processes, and benefits of designing for usability.
Launching Your SaMD Solution in 2025: Key SaMD Trends and Proven Best Practices
Explore the top SaMD trends and best practices for successfully launching your SaMD solution in 2025. From AI advancements to regulatory updates, learn how to navigate the challenges and seize opportunities in the evolving digital health landscape.