Medical Devices Quality Management System
Safe devices... protected lives... guaranteed healthy future
ما هو ISO 13485:2016؟
أهم متطلبات تطبيق المعيار
The system covers all stages of medical device lifecycle
design and development, manufacturing and production, distribution and marketing, installation and maintenance, post
market surveillance, risk management, document control, training and qualification.
من يحتاج للحصول على الشهادة؟
لماذا هذا المعيار مهم لمنشأتك؟
Because the global medical device market is worth $432 billion, and 95% of advanced markets require this standard. System implementation achieves
access to all global markets, 90% reduction in product risks, increased physician and patient trust, improved quality and reliability, avoiding fines and recalls.
هل أنت مستعد لرفع مستوى منشأتك؟
انضم إلى قائمة عملائنا المتميزين واحصل على شهادة ISO 13485:2016 بكل سهولة واحترافية.
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