Ophthalmic medical devices address significant global health needs, as over 2.2 billion people face vision impairment, much of which is preventable or treatable. These devices range from low-risk ...

Specialty Coating Systems (SCS) offers a variety medical coatings and technologies to support a range of medical device applications, including elastomeric seals, forming mandrels, pacemaker ...

Cryostorage bags are critical for preserving biologics and cellular therapies, yet their reliance on fusion-sealed seams and ports creates inherent vulnerabilities. When these containers are exposed ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

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 ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

This is the second in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in December of 2019 and supported by guidance in the ISO TR ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

The wearable medical device industry sits at the intersection of life sciences regulation and rapidly-evolving technology law. Companies in this space face overlapping legal frameworks that can ...

Throughout this series, I have focused on plastic parts used in your medical device and the associated mold production process. I began with the fundamentals needed to define and design a plastic part ...