Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments ...

Few life sciences companies are ready for a disaster, particularly a cyber one. Key factors include an integrated approach to ...

Medical device labeling must show many elements, such as manufacturer information, product information, intended use, indications for use, instructions for use, information regarding sterile ...

Eurofins’ San Jose EO sterilization site offers fast, high-quality sterilization services for medical devices, ensuring ...

Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is ...

If you are in the medical device development industry, and selling your own devices, you likely know you need a quality management system (QMS). A QMS helps ensure that manufactured devices meet all ...

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 ...

A major European contract manufacturing organization (CMO) producing diverse biologic drugs recognized the significant impact of the August 2023 EU GMP Annex 1 revision. This update, focused on ...

In August 2022, the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most ...

SMC provides manufacturing and assembly services for full devices or subassemblies for finished devices. Our global facilities offer ISO 13485 systems for assembly as well as kitting and packaging ...