Mariacarey

Mariacarey

added blog Health
2024-06-26 17:58:07 - Translate -

Advantages of Obtaining UK Quality Management Certification for Your Medical Device Business.
Summary UK Quality Management Certification is essential for UK medical device manufacturers, ensuring compliance with international standards and UK ISO 13485 Services requirements. It covers the entire product lifecycle, including design, production, and distribution, and applies to both internal and external stakeholders. Achieving UK Quality Management Certification can enhance safety,...

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Mariacarey

added blog Health
2024-05-31 08:52:16 - Translate -

Achieving UK Quality Management Certification and UK ISO 13485 Services.
Summary: UK Quality Management Certification is the internationally recognized quality management system standard specific to the medical device industry. It mandates comprehensive requirements for establishing and maintaining robust QMS processes to ensure quality and regulatory compliance in medical device design, production, and servicing. Key components encompass risk management,...

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Mariacarey

added blog Health
2024-05-28 09:14:39 - Translate -

Deciphering Medical Device Registration in the EU: A Comprehensive Handbook.
Introduction: Navigating the regulatory maze of medical devices within the European Union (EU) can be daunting, particularly concerning registration. This comprehensive guide aims to empower manufacturers with the requisite knowledge to effectively navigate the Medical Device Registration EU process, ensuring compliance with the Medical Devices Regulation (MDR) and instilling confidence...

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Mariacarey

added blog Other
2024-05-06 07:15:45 - Translate -

The Vital Role of Thorough Documentation in Achieving MDR Compliance
In the dynamic landscape of medical device regulation, comprehensive documentation emerges as a cornerstone for MDR Compliance, fostering transparency, traceability, and accountability throughout the entire lifecycle of medical devices. This article delves into the pivotal significance of thorough documentation, shedding light on its indispensable role in affirming adherence to safety and...

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Mariacarey

updated the profile picture
2024-04-10 11:12:14 - Translate -

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