When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more effectively. The following article outlines how companies can identify the appropriate degree of testing rigor for risk-based CSA validation to ensure the least burdensome approach.
Smart hospitals are revolutionizing health care with the help of AI, IoT and robotics. Following are the latest technology and data analytics tools and trends that are helping these hospitals of the future provide safer, more personalized care.
Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
Internet-enabled medical technologies have significantly improved the standard of care. They have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news is these issues can be mitigated—or, in some cases, eliminated—in the engineering and design phase. Following are five key considerations for manufacturers to help foster connected healthcare’s continued acceleration.
MedTech is evolving from siloed products and devices to increasingly multi-functional and integrated digital systems, and device manufacturers are faced with significant challenges in bringing these connected solutions to market. Slow and expensive development lifecycles, complex and inflexible device architectures, and the need for increased cybersecurity, are among the key challenges. The solution lies in a new generation of devices powered by intelligent software data flow.
Cybersecurity in health care is anything but simple. But significant changes can be expected in the coming years.
A new guide from the Healthcare and Public Health Sector Coordinating Council recommends cybersecurity strategies that manufacturers and health providers can implement for legacy medical technology as a shared responsibility in the clinical environment, and provides insights for designing future devices that are more secure.
Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
Connected medical devices have many advantages but require a higher level of security. If the medical industry doesn’t improve its cybersecurity posture, it could endanger patient privacy and lives.
