In medical instrument and device production, surface finish is a critical factor in safety, functionality and regulatory ...

On February 2, 2024, the FDA issued the first of these policies: a final rule amending the medical device Current Good Manufacturing Practice requirements of the Quality System Regulation (QSR) to ...

Medical device battery manufacturers and systems: Introduction In the industry of global healthcare technology, the role and importance of a reliable medical device battery manufacturer cannot be ...

ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard.

Though it is a European guide for manufacturing, EU GMP Annex 1’s impact is global. So how does the latest revision affect you? ... Updated Air Monitoring Requirements for Medical Device Manufacturers ...

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

Compliance with ISO 13485 (Quality Management Systems for Medical Devices) and FDA requirements is crucial, and CNC procedures are intended to meet these standards. Quality assurance is included ...