دانلود کتاب توسعه سیستم مدیریت کیفیت – گواهی ISO 13485 – راهنمای پیاده سازی برای صنعت تجهیزات پزشکی

This book is based on my personal experience from developing, running, and certifying an ISO 13485:2016 Quality Management System for my young medical device startup. I am one of the founders of the company and the one tasked with figuring out our QMS as our quality manager. I am also the chief operations officer and a longtime board member of our company, so I have had the privilege of seeing all our operations mature and fi nding out how quality management can fit in on several levels of the organization. I have not done this alone. In addition to a great Quality Management Team and our generally stellar staff at the startup, I have also had quality con­sultants available for consultation on those occasions I have wanted some expert feedback. On top of this, I have had the fantastic network of peers I have been lucky enough to build over the years.