iso 13485 Certification

   What is ISO 13485 Certification? ISO 13485 is an internationally recognized quality management standard specifically for the medical device industry. It outlines a comprehensive quality management system that helps organizations design and manufacture safe and effective medical devices. Certification to ISO 13485 is a validation that a company has implemented the standard successfully and is committed to continual improvement. The Duration of Getting ISO 13485 Certified The duration of getting ISO 13485 certified can vary depending on the size and complexity of your organization as well as how prepared you are for the assessment. Generally, it takes 3-12 months to get certified. The duration can get affected by various factors such as: The size of the organization The size of the organization is one of the primary factors that can affect the duration of getting ISO 13485 certified. Generally speaking, larger organizations will take longer to certify than smaller organizatio...