Medical Devices Blog


Corrective and Preventive Actions (CAPA) for Medical Devices Explained
Corrective and Preventive Actions (CAPA) are essential components of quality management systems (QMS) in the medical device industry, designed to

Internal Audits: Ensuring Compliance and Quality in Medical Devices
Internal audits play a pivotal role in the quality management systems (QMS) of medical device manufacturers, serving as a proactive

Documentation and Record-Keeping Best Practices for Medical Devices
In the realm of medical devices, meticulous documentation and record-keeping are not just regulatory requirements but crucial components of ensuring

Building an Effective Quality Management System (QMS) for Medical Devices
Building and maintaining a robust Quality Management System (QMS) is essential for medical device manufacturers to ensure compliance with regulatory

Verification and Validation Processes for Medical Devices
Verification and validation (V&V) are integral processes in the lifecycle of medical devices, playing crucial roles in ensuring regulatory compliance,

Incorporating Safety in Medical Device Design
Safety is paramount in the design of medical devices, influencing every stage from concept development to market launch. This article