Medical Device Management
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Testing Requirements: Medical Electrical Equipment System
Testing medical electrical equipment systems is an integral process in ensuring the safety, reliability, and efficacy of these devices within the healthcare industry. This process is governed by stringent standards that outline the requirements and methodologies for such evaluations. 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.
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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.
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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.
Our
Services
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Service and Maintenance
Ensure device compliance and performance with our comprehensive service and maintenance.
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Asset Management
Optimise device performance with tailored asset management for sustained reliability.
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Post-market Surveillance
Proactive post-market surveillance actions to ensure ongoing safety and compliance.
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Training Courses
Build expertise with our technical training courses for effective device management.
Managing Medical Devices Since 2015
Established in 2015, EBME Solutions was born from a recognition of gaps in local community medical device management. With founders experienced in the NHS, our mission is to support colleagues in delivering safe and sustainable healthcare. At the core of EBME Solutions lies an unwavering commitment to quality, collaboration and patient safety, shaping our distinctive approach to device management.
Our team, with over twenty years of combined experience, are experts in medical device maintenance and governance. Tailoring services to individual client needs, we provide, safe, and sustainable solutions. Training programs embody a philosophy of collaboration and continual improvement, shaped by scientific theories, industry best practices, and regulatory requirements.
In post-market surveillance, we actively engage with manufacturers and users, remaining abreast of MHRA regulations. Our vision for healthcare involves active engagement with patients and clients, advocating safety, sustainability, and ongoing improvement in medical device management.
Envisioning a future of healthcare, we actively engage with patients and clients, championing safety, sustainability, and continuous improvement in medical device management. Join us on this journey as we positively impact patient experience.
