In another first for warning letters, complaint handling supplanted CAPA as the violation found most in letters. 1 Medical device manufacturers often struggle to keep up with complaint investigations ...

Annex IV (EC Declaration of Conformity – Full Quality Assurance System) of the IVDD (98/79/EC) is all about delineating specific regulatory requirement for devices falling under List A of Annex II.

An increasing number of medical devices incorporate artificial intelligence (AI) capabilities to support therapeutic and diagnostic applications. In spite of the risks connected with this innovative ...

Introduction: A Wake-Up Call from Recent History In the world of MedTech, traditional development processes often slow down innovation. Medical device manufacturers face an environment where global ...

Fabricio Pamplona, Ph.D., is the founder of Mind the Graph, an online platform that offers thousands of accurate medical illustrations that users can download. Pamplona has a background in ...

In February, Hologic received FDA clearance for its Genius Digital Diagnostics System, which combines advanced imaging with AI-assisted review for cervical cancer screening. We spoke with Mike Quick, ...

Globally, according to a number of estimates, the healthcare 3-D printing industry is forecast to be worth about $3 billion by 2024 with a growth rate of about 20% per year. With the rise of ...

Keeping lab equipment operational is crucial for both safety and efficiency, but it’s often more challenging than it appears. As this machinery grows increasingly sophisticated, there are more ways in ...

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of ...

As has been widely noted, the COVID-19 pandemic has prompted countless people to rely on telehealth and virtual monitoring for their healthcare needs. This dramatic pivot is catalyzing a demand for ...

The healthcare industry is a complex web of clinical, administrative, regulatory, and financial processes. Despite the advancements in health information technology and artificial intelligence, ...

As of October 2023, the FDA had identified 692 artificial intelligence/machine learning- enabled products that received clearance for marketing, with sustained growth projected for both submission ...