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What You Need to Know About the ISO 13485:2016 Update

May 21, 2018 By MassDevice Leave a Comment

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 […]

Filed Under: Whitepapers Tagged With: Proven Process

Building Safety and Security into Connected Medical Devices

May 4, 2018 By MassDevice Leave a Comment

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 […]

Filed Under: Whitepapers Tagged With: Green Hills Software

Design for Manufacturing Breakthroughs: Producing Innovative Micro Medical Devices

April 30, 2018 By MassDevice Leave a Comment

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, […]

Filed Under: Whitepapers Tagged With: MTD Micro Molding

LVAD Efficiency and the Criticality of Accurate Blood Pressure Measurement

April 18, 2018 By MassDevice Leave a Comment

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 […]

Filed Under: Whitepapers Tagged With: Proven Process

Things You Need to Consider When Designing Robots for Commercialization

March 16, 2018 By MassDevice Leave a Comment

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 […]

Filed Under: Robotics, Whitepapers

Current Regulatory Landscape for EO Residue Levels in Medical Devices

January 30, 2018 By MassDevice Leave a Comment

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 […]

Filed Under: Whitepapers Tagged With: nelsonlaboratories

3 Steps to Increase the Accuracy and Speed of Your Next Medical Device Recall

December 5, 2017 By MassDevice Leave a Comment

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 […]

Filed Under: Whitepapers Tagged With: Novasyte

The Case for Real-World Evidence (RWE) in Medical Device Development

November 30, 2017 By MassDevice Leave a Comment

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 […]

Filed Under: Whitepapers Tagged With: Proven Process

New Study Reveals How Medical Device Companies Can Earn Trust and Drive Revenue Growth

October 24, 2017 By MassDevice Leave a Comment

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 […]

Filed Under: Whitepapers Tagged With: Partners & Simons

How to Write a Great Monitoring Report

October 10, 2017 By MassDevice Leave a Comment

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 […]

Filed Under: Whitepapers Tagged With: IMARC

Micro Molding with Bioabsorbables: Not Your Average Thermoplastics

October 4, 2017 By MassDevice Leave a Comment

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 […]

Filed Under: Whitepapers Tagged With: MTD Micro Molding

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