Clinical Investigation of Medical Devices Management

Safe research... reliable results... responsible innovation

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تعريف المعيار

ما هو ISO 14155:2020؟

ISO 14155:2020 is your comprehensive guide for conducting clinical investigations of medical devices with the highest safety and quality standards, ensuring participant protection, result reliability, and compliance with global ethical and regulatory standards.

المتطلبات الأساسية

أهم متطلبات تطبيق المعيار

The standard covers all clinical trial phases

planning and design, participant selection, conducting trials, data collection, statistical analysis, risk management, monitoring and follow

up, documentation and reporting, ethical compliance.

الفئات المستهدفة

من يحتاج للحصول على الشهادة؟

Vital for all medical device development participants

medical device companies, medical research centers, university hospitals, contract research organizations, regulatory bodies, clinical trial centers.

القيمة المضافة

لماذا هذا المعيار مهم لمنشأتك؟

Because medical device development requires investments up to $94 million, and 90% of devices fail in clinical trials due to poor planning. Standard implementation achieves

75% increase in trial success, reduced costs and time, safety assurance, regulatory compliance.

هل أنت مستعد لرفع مستوى منشأتك؟

انضم إلى قائمة عملائنا المتميزين واحصل على شهادة ISO 14155:2020 بكل سهولة واحترافية.

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معايير مشابهة

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