What is ISO 13485:2016?ISO 13485:2016 is an international standard that specifies requirements for a Quality Management System (QMS) for organizations involved in the design, production, and distribution of medical devices.Who should consider ISO 13485:2016 certification?Organizations of any size involved in the medical device industry—such as manufacturers, suppliers, and service providers—should consider certification to ensure product quality and regulatory compliance.What are the key changes from ISO 13485:2003 to ISO 13485:2016?Key changes include a stronger emphasis on risk management, more detailed requirements for documentation, and increased focus on the regulatory environment.
Ten si v této souvislosti všímá, že z místa se za posledních deset let nepohnuly ani české akcie. Naproti tomu hodnota hlavního indexu amerických akcií S&P 500 se téměř ztrojnásobila, japonský akciový index Nikkei 225 se více než…
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