Medical device document approvals seem to be a roadblock when you are the most pressed for time. But if the right approvers ...

Discover how thinXXS helped Pattern Bioscience accelerate digital droplet chip development through precision manufacturing, ...

Examine how medical device manufacturers can improve the economics and reliability of orthopedic implants by rethinking both material selection and processing strategies. Ultra-high-molecular-weight ...

Discover how integrated microfluidic pumping solutions eliminate bulky external equipment, simplifying cartridge design while ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

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

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 ...

On Dec. 8, 2021, CEN, the European standards body, released an amendment to the European edition of the medical device risk management standard, EN ISO 14971:2019, amendment A11:2021. This edition, ...

The beauty devices business is booming. The global value of the cosmetic industry amounted to over $530 billion in 2022, with an expected growth rate of roughly 4% over the next five years, while the ...

The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...

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 ...