Insights
Here we share our unique insights into the complexities of software development for MedTech, Life Sciences and Robotics solutions.
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Time Is Ticking: Prepare Now for QMSR Compliance by the 2026 Deadline
The FDA’s transition to QMSR, effective February 2, 2026, marks a major shift aligning U.S. quality regulations with ISO 13485:2016. Discover what this means for MedTech companies, including key compliance challenges and steps to take now to stay audit ready. Read more to ensure your quality system is prepared.
FDA Cybersecurity Guidance SSDLC SPDF: What You Need to Know
The FDA’s latest guidance emphasizes the critical importance of integrating cybersecurity throughout the medical device development lifecycle. At MedAcuity, we break down how implementing a Secure Product Development Framework (SPDF) and a Secure Software Development Lifecycle (SSDLC) can help manufacturers meet these evolving regulatory expectations—reducing risk, ensuring patient safety, and improving time to market.
From Concept to Compliance: The Role of Requirements in Robotics Development
Unlock the full potential of your robotics development by starting with clear, well-defined requirements—it's the difference between costly setbacks and a streamlined, successful launch. In a collaborative white paper from MedAcuity and Kinova, discover how a structured approach to requirements definition helps robotics teams avoid common pitfalls like scope creep, rework, and compliance issues, laying the foundation for long-term success.
Optimizing MedTech Connectivity and Security
DDS communication frameworks to deliver innovative and secure solutions for the MedTech and Robotics industries
Medical Device Development
Discover the truth behind the perceived conflict between data exchange and device security.
AI in Healthcare
Artificial intelligence, Augmented Intelligence, Augmented Reality, and Machine Learning (collectively referred to as AI technologies) are revolutionizing the healthcare industry.
Identifying and Mitigating Premarket Submission Risks
In 2021, FDA reviewers found major deficiencies in an estimated 80% of PMA submissions and in 67% of 510(k) submissions. The numbers associated with premarket submission failures are interesting and truly alarming but on their own tell only part of the story.
Medical Devices: Connectivity Concerns
As our healthcare ecosystem continues to evolve, becoming ever more complex and distributed, so must the devices and solutions being developed for this ecosystem. Check out our INSIGHTS into how Medical Device OEMs can succeed and ensure the acceptance of their premarket submissions, and ultimately, adoption of their connected devices and solutions.
Managing Large Robotics Software Teams: 6 Critical Lessons Learned (the hard way)
Developing a robot is more complicated than a standard embedded software implementation.
Cybersecurity For Today’s Complex Healthcare Ecosystem: Effective Strategies Start at the Top
The risk of cyber threats to the global healthcare system is undeniable–and growing.
