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 ...

This application note provides a list of tips for operating an Avalanche Photodiode (APD) arrays with a guard ring in a range of applications, as well as an overview of each ADP array series and their ...

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.

The FDA can’t physically be at every medical device manufacturing facility every day to ensure the safety and reliability of products. What it can do is enforce a system of continuous self-improvement ...

The company's lubricious coatings improve medical devices by reducing the coefficient of friction by up to 90% on a vast array of surfaces including vascular catheters, urinary catheters, and ...

Technical Innovations, Inc.art Driller is a table-top drilling machine. It is three-axis, computer numerical controlled (CNC): X-axis (horizontal resolution to 0.0003125 in.); rotary-axis (rotational ...

Experience the next generation of biopharma innovation with PharmaLok™ ZerO sanitary clamps. Designed to simplify and streamline biopharma processes, these advanced clamps feature a universal fit and ...