5164153777https://smlouvy.gov.cz/smlouva/537772016-08-03T07:28:15 02:00gg4t8hfPovodí Vltavy, státní podnik70889953Holečkova 106/8, 15000 Praha 5, CZ16xtxuxaRL-stav s.r.o.27963691Družstevní 12, 330 11 Třemošná1Smlouva o dílo - výchovná…
Get ISO 13485:2016 certification to enhance your medical device quality management, ensure compliance, and boost customer confidence.
Neobsahuje albertberounci
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.