Designing for Human Factors Standards
Medical device usability and how to efficiently integrate new regulatory standards into the product development process seems to be on a lot of people’s minds at the moment.
Smart Toilet Seat Wins FDA Nod to Monitor Heart Rate
Casana has developed a unique way of measuring a person’s heart rate and oxygen saturation. The Rochester, NY-based company is measuring a patient’s vitals with its smart toilet, the Heart Seat.
Sensors: The Heart of Minimally Invasive Equipment Technology
Through the years, minimally invasive equipment technology has grown exponentially, offering new ways for doctors to diagnose and treat their patients.
How can antimicrobials prevent healthcare-associated infections?
In the past century, modern medicine has broken countless barriers towards a safer, more effective healthcare protocol.
Optimizing UX for the Internet of Medical Things
The implementation of the Internet of Things (IoT) in healthcare is growing rapidly. The industry is seeing an increased need for workflow optimization for electronic health records (EHRs), smart devices, wearables, patient portals, and remote healthcare access.
Pushing the Limits of Possibility in Medical Devices
In 2016, FDA approved Medtronic’s Micra, the firs […]
FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers
The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive review of test protocols and results for each submission, a process that can be burdensome for both manufacturers and regulatory bodies.
Top-quality medical grade TPUs enabled by smart factory: ICP DAS – BMP to exhibit at Medtec China 2023
The company will showcase its prime quality TPUs to worldwide visitors at Medtec China 2023, June 1-3, Suzhou.
Don’t Fear the Audit: Benefits of Good Quality Practices
Quality is a loaded word. For the general public, it connotes excellence, value, worth—all of which we strive for in our business. But for some in the medical device industry, it’s about bureaucracy, liability, and conflict. Maintaining a quality management system (QMS) per the expectations of regulatory bodies can be time-consuming, confusing, expensive, and tedious.
Stratasys and CollPlant Partner to Bioprint Breast Implants
When it comes to 3D printing in healthcare, a long-term goal has been to print human tissue that can potentially be grown into new organs. While 3D printing a new heart for a patient isn’t currently a reality, a growing number of companies are developing their own methods of printing tissue that can be used in implants, and, they hope, eventually organs.
