-Operon Strategist ISO 9001,ISO 13485 consultant for medical device manufacturers. -Operon Strategist are providing ISO 13485 consulting service for medical device manufacturers.ISO 13485 is a quality system standard designed for medical device companies. The international quality management systems for the design and manufacturers of medical devices can help company stand out.
Why you choose perestechnology? As a certified ISO 13485 and FDA registered facility, we have the proven reliability to ensure your project success. To Check all of our certificates please visit . #medical #project #technology
FreshKon is a global brand with its range of cosmetic lenses selling in more than 50 countries. With over 25 years of experience in manufacturing and supplying high quality contact lens and contact lens care products to optical retailers and eye-care practitioners, FreshKon is manufactured in accordance to the quality assurance system ISO 9001 / ISO 13485 requirements and meet the Medical Devices Directive 93/42/EEC.
ISO 13485 is where an organization needs to demonstrate its ability to provide medical devices and related services consistently meet customer requirements and regulatory requirements. http://www.omnex.com/training/iso13485/iso13485-medical-devices-fda-cfr-21-training.aspx