ISO 13485:2016: An Introduction The international standard ISO 13485 governs the manufacture of medical devices. The first edition was published by the International Organization for Standardization (ISO) in 1996. The ISO currently reviews standards at least every five years to determine whether they need to be updated. The first update to ISO 13485 was released […]
Building Safety and Security into Connected Medical Devices
Medical devices are being designed to encapsulate virtually all of the functionality and complexity within the software. Considering today’s technologically advanced threat landscape, building in safety and security has never been more important. Cyber-criminals are using vulnerable network connected medical devices as a gateway to install malware on hospital networks. It is essential for manufacturers […]
Design for Manufacturing Breakthroughs: Producing Innovative Micro Medical Devices
This whitepaper explores how medical micro breakthrough designs are produced and how supplier and design roadblocks can be overcome without compromising the original design. By learning how to efficiently work with a molder to produce a breakthrough idea, medical OEMs can save valuable time in their supplier qualification process, decrease costs, increase speed to market, […]
LVAD Efficiency and the Criticality of Accurate Blood Pressure Measurement
What is a LVAD? How does it work? A left ventricular assist device (LVAD), also called a ventricular assist system or VAS, is a mechanical pump that is attached to the left ventricle of the heart to augment the function of the heart’s main pumping chamber. The left ventricle pumps blood from the heart to […]
Things You Need to Consider When Designing Robots for Commercialization
When people think of robotics, they often think about warehouses or manufacturing lines, where robots automate multiple processes. But robotics has the potential to reshape the way healthcare is delivered in a variety of applications and locales. While we’re a long way from a robot replacing a physician, there are many opportunities to provide automation […]
Current Regulatory Landscape for EO Residue Levels in Medical Devices
One of many crucial steps a single-use medical device takes on its journey from concept to commercial product is sterilization. Ethylene oxide gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other potentially dangerous living microbes from medical devices; however, manufacturers must take care to control and […]
3 Steps to Increase the Accuracy and Speed of Your Next Medical Device Recall
Recalls in the med-tech industry aren’t going away. In this white paper, you’ll find proven strategies to increase the efficiency of your recall strategy. These have been developed through our experience working with several of the largest med-tech companies in North America, who have told us that this method is “changing the way all recalls […]
The Case for Real-World Evidence (RWE) in Medical Device Development
Medical Devices are used in the real world every day, so shouldn’t they be tested in the real world? You would think so. But the FDA hasn’t necessarily been of that mindset — until now. Per FDA regulations, testing has to be conducted under supervised clinical trials, which have pre-designed protocols. When most think of […]
New Study Reveals How Medical Device Companies Can Earn Trust and Drive Revenue Growth
To meet the needs of the triple aim and help improve operational and cost efficiencies, hospital executives are looking for manufacturers to move beyond products to become problem solvers. With this in mind, medtech companies can deliver end-to-end solutions hospitals need, an opportunity worth $44 billion in the U.S., to help them transform the way […]
How to Write a Great Monitoring Report
Writing monitoring reports is an important responsibility. A well-written monitoring report tells the story of your clinical trial to the FDA and helps facilitate inspections. However, this important task doesn’t often get the attention it deserves. Between scheduling visits, traveling and conducting the visits, it can fall down on a monitor’s priority list. IMARC has […]
Micro Molding with Bioabsorbables: Not Your Average Thermoplastics
For micro medical components, there is a wide variety of materials to choose from and many new micro medical applications are relying on bioabsorbable materials because the materials dissolve or absorb into the body, eliminating the need for additional surgeries and minimizing concerns about adverse effects. Across the board with plastics, the rules are different […]
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