The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
The world of physics has a foundation built on beautiful universal constants, which work their way steadfastly into the equations governing electrodynamics, and then further extend themselves into our very hands in the design of smart interconnected electrical devices that...
The new European Union (EU) Medical Device Regulation (MDR) will impact medical device manufacturers’ product-development timelines. All companies intending to sell their devices in Europe must understand the new MDR and how it differs from the previous directives, especially in...
Medical devices marketed in the European Union are required to comply with a set of medical device directives called the “medical devices regulation” or MDR for their Conformité Européenne (CE) marking and marketing in Europe. Over the past decades, the...
For three decades, the ISO 10993 international standard series has provided the overarching guidance on evaluating medical devices for biocompatibility. The new international standard, ISO 18562, addresses gaps. Here’s what you need to know. Read the Full Story in Medical Design...
Here are some takeaways from ISO 19227 for orthopedic implants. ISO 19227 Implants for Surgery–Cleanliness of Orthopedic Implants–General Requirements is a long-awaited guidance document that was finalized and published early 2018. This guidance document is intended to assist orthopedic medical...
