Managing global PFAS regulations demands a proactive strategy. Identifying and mitigating both intentional and unintentional ...

In micro-manufacturing, supplier choice significantly determines success. Explore how one company transformed a struggling ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

We are sure you are aware that the EU medical devices framework has been subject to significant changes over recent years. However, implementation of the new rules has been problematic since the ...

The European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) impose stringent requirements on all economic operators involved in the supply chain of ...

ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry. 1 The guidance’s influence sometimes extends well beyond just medical devices. The ...

Surgical navigation and robotic systems are not novel technologies and have had a historical presence since the 19th century. Surgical navigation is a result of evolution from a frame-based stereotaxy ...

Pressures on healthcare systems are set to become worse with aging populations requiring round-the-clock care and an exponential increase in chronic diseases. Technology-led smart solutions are ...

Getting a medical device through concept development, prototyping, design, and the regulatory process is hard enough for any developer. It’s no wonder that assembly and packaging are often ...

Medical device manufacturers have traditionally focused on designing devices that are safe and effective to use. This will continue to be the main concern, but there is now more pressure on ...

In the previous article, “How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint,” we discussed key factors for maintaining operational excellence to achieve cost reduction ...