When it comes to understanding which colors to choose, how to apply color and why, and what kinds of materials and surface finish create the most value, design expertise and direction is required. It’s time to make medical products object of desire rather than disinclination.
Hose barbs are a common feature on fittings and connectors. However, several key factors need to be considered when designing these. This column discusses how all barbs are not created equal.
Two takeaways this week are immensely important for device manufacturers: 1. Make sure maximum effort is exuded during the documenting and validation of the manufacturing processes, and 2. Manufacturers must take an active part in determining appropriate sample sizes for verification testing; do not let notified bodies make this decision without your input.
Two takeaways this week are immensely important for device manufacturers: 1. Make sure maximum effort is exuded during the documenting and validation of the manufacturing processes, and 2. Manufacturers must take an active part in determining appropriate sample sizes for verification testing; do not let notified bodies make this decision without your input.
Liquid Silicone Rubber or LSR is a thermoset elastomer based on silicone dioxide (sand). And in recent years, use of LSR is growing in usage and popularity. This installment of Ask the Engineer addresses some questions on uses of LSR in medical devices, how it can be injection molded, and 2K molding (multi-component LSR molding).
This week’s guidance is all about examination; notified bodies are required to examine and certify that samples provided as representative of the device manufacturer’s manufacturing process actually comply with all aspects of the IVDD.
If an organization is familiar with the challenges associated with complying with the regulatory requirements associated with a Class III device under the MDD, understanding and complying with Annex IV of the IVDD should be a proverbial “cakewalk,” then again, maybe not.
Which materials make the most sustainable sense and for what applications? How can we create products that balance function with recycling opportunities? With new materials available and on the horizon, the balance point is shifting toward a place that’s more sustainable.
This weeks guidance delineates the steps that a device manufacturer must perform in the pursuit of making application to their notified body. The end result of a successful application process will be the authorization to affix the CE mark of registration onto product packaging and the entry of product into commerce within the EU.
Annex II of the IVDD is critical as it ultimately drives the path for establishing and complying with essential requirements, and hopefully, the eventual approval from your notified body. And significant changes to Annex II are coming.
Most databases today aren’t adaptable; it’s hard and the benefits aren’t significant enough to make the effort worthwhile. Most companies with products of various sizes have relatively few variations (think S, M, L, XL); and in this case, adaptability is superfluous.
