Medical Device Consulting Resources
Looking to enhance your knowledge of all things SaMD or find inspiration for your next project? Explore our featured collection of case studies and educational materials designed to empower healthcare innovators by sharing our medical device consulting expertise and real-world results. Delve into topics such as following SaMD best practices, achieving regulatory clearances, developing quality management systems, improving operational performance, and more!
Case Study
Intelliguard Bolsters Software Development, Streamlines Client Migrations, and Achieves FDA Compliance for SaMD with CieloWorks
Case Study
PPTA Helps Ensure Plasma Donation Safety, Streamlines SaMD Application Usability, and is Granted 510K Clearance with CieloWorks
Article
From Silos to Synergy: The Importance of Guided Collaboration in Medical Software Development
Article
3 Ways to Expedite Market Entry for Healthcare and Medical Device Software
Article
Mastering SaMD and Healthcare Software Development: Best Practices and Key Considerations
Infographic
Guided Collaboration: Breaking Down Silos and Boosting Innovation in Medical Software Development
Article
Reducing Complexity in Healthcare and Medical Device Software Development: 3 Pitfalls and How to Avoid Them
Article
Building a Culture of Quality: The Importance of Quality Management System and a Quality-First Mindset in Healthcare and Medical Device Software
Article
The QMSR Countdown: What SaMD Teams Must Do Before the February 2026 FDA ISO 13485 Standard Deadline
Article
Designing for Medical Device Regulations: Early Integration of Quality and Regulatory in R&D
Article
Preparing for FDA QMSR: Strengthening Purchasing Controls for Compliance
Article
The ROI of a SaMD Consultant: Why Early Investment in Strategic Advisors Pays Off in SaMD Development
Article
The Path From FDA 510(k) Clearance to Product Launch