Testing Requirements: Medical Electrical Equipment System
This article provides an in-depth overview of the testing requirements for medical electrical equipment systems and the diverse setups that fall under this classification.
The Evolution of Medical Equipment Safety: The Crucial Role of IEC 62353
IEC 62353 marks a pivotal advancement in medical device safety, providing a comprehensive framework for the routine testing of healthcare equipment. It ensures sustained device safety for patient use through streamlined testing procedures. This standard represents a significant stride towards global uniformity in medical equipment management, blending meticulous safety evaluations with operational efficiency.
UK Medical Device Regulatory Landscape
Explore the evolving UK regulatory landscape for medical device certification and commercialisation post-Brexit. Understand key changes, the role of the MHRA, and the UKCA marking process, along with the challenges and opportunities for manufacturers in the UK's unique regulatory environment. This comprehensive guide offers insights into navigating the UK and EU regulations, ensuring compliance, and leveraging opportunities for innovation in the medical device sector.