Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the ...

In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...

The DEA has announced new rules for remote prescription of controlled substances. As telehealth adoption grows, regulatory ...

A new concept in ampoule packaging, molded entirely of plastic and safe for unlimited consumer use, is available from James Alexander Corporation under the brand name plastiqueAmp A new concept in ...

The SRC-MED Series of medical silicone caps from Caplugs are designed to protect the ends of medical instruments, tube ends, and other delicate projections. With a wide range of 31 available sizes and ...

The Journal of Validation Technology is a peer reviewed journal exclusively dedicated to providing practical approaches to conducting effective validations Institute of Validation Technology of ...

Last month, the FDA quietly finalized a new guidance that is likely applicable to the majority of Med Device Online’s audience. The guidance, which goes into effect on October 1, spells out the agency ...

This article explains the importance of understanding and stating a dynamic range correctly. This paper also provides insight on how Ophir-Spiricon, a global leader in precision infrared optics and ...

One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain.

Both the BTC IIS and TTC IIS Series by Parker Hannifin comprise brush and brushless DC motor driven pumps ideal for medical applications such as anesthesia monitors, CO2 monitors, wound therapy, ...

Source: RAM Optical Instrumentation, Inc. The Optical Video Probe from RAM Optical Instrumentation is an optical video package that delivers zoom microscope-type viewing RAM Optical Instrumentation, ...