Over the course of time, the ISO 2859 standard has established itself as an indispensable tool, not only for medical device manufacturers, but also for a wide range of manufacturing

In the current practice, the process of cleaning validation became essential for the life science sector, especially for the pharmaceutical sector but also for the medical device sector. Cleaning validation can be

Introduction to MDR QMS Requirements A complete and comprehensive understanding of the EU MDR QMS requirements is becoming essential for an effective implementation of the New European Medical Device Regulations. We

Regulated environments as medical devices or pharmaceutical sectors requirer the organisations to undergo audits from notify body or competent authorities; ISO organization published the ISO 19011 to define the process

Internal audits are one of the most important process within a Quality Management System for Medical Device manufacturers and having an ISO 13485 Audit Checklist is an essential