Balancing Compliance and Quality in Medical Device Manufacturing
As the pace of innovation further accelerates in 2021, and the need to get new devices to market intensifies, maintaining adherence to regulatory controls is not enough……
How to Achieve Quality through Process Validation
With any manufacturing process, you want certainty in the quality of your products. As you scale production from hundreds or thousands into the millions, you want to know with a high level of confidence that your process produces good parts with consistency……
Medtech Needs to Reconsider Its Approach to Cybersecurity
The research was unveiled at the ACC.21 Scientific Sessions. Researchers used Ultromics’s cloud-based AI platform to review the data……
One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain
Manufacturers continue to face a lack of clarity, high costs, and manual processes in order to comply with the new medical device regulation (EU MDR), according to a recent survey. These results come one year after the regulation’s postponement and a few weeks before the new validity date……
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How to Design an Elegantly Simple Medtech Product
As healthcare becomes increasingly complex, one of the biggest challenges engineers face is in making the product as simple for the end-user as possible. Here are some best practices for designing an elegantly simple medtech product, as shared during the Medtech Design Summit 2021……
Protecting Hearing Aids Electronics with Parylene Conformal Coatings
Nano-conformal coatings company HZO has developed a new Parylene coating option utilizing high-throughput coating equipment and automated processing systems for efficient manufacturing……
BD Taps Contract Packager for COVID-19 Test Kits
With help from a nimble partner, medical device giant BD took its rapid COVID-19 test kit from concept to large-scale production in a matter of months……
A Digitalization Tipping Point for the Medical Manufacturing Supply Chain
Many medical manufacturers are embracing digital transformation as a means to gain agility and efficiency…….
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Advances in Catheter Manufacturing
MD&M BIOMEDigital speakers discussed materials and complex shaft designs for catheter manufacturing……
Electroporation—Innovation in Tissue Ablation and Large-Molecule Delivery
Applying specific electric pulses near targeted cells—and using appropriately designed equipment and electrodes—can enhance ablation, chemotherapy, and drug-delivery procedures……
