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We will strive to maintain compliance with ISO 13485:2016 and 21CFR Part 820 with a focus on continuous improvement as well as continual monitoring and measurement of our core process metrics to ensure effectiveness.ĪSB has developed, documented, implemented, maintained and continually improves its Quality System to ensure compliance with national and international Quality Systems standards and regulations and to ensure that products adhere to specified requirements, including but not limited to: the FDA Quality Systems Regulations (QSR) 21 CFR Part 820 and ISO 13485:2016.ĪSB provides the design, development, and testing for the manufacture of world-class biomaterials focused on customer-driven solutions for the medical device industry. Although GMP - certified cell culture media do not exist on the market. Internal audits, GAP analysis and implementation of quality systems according to GMP (EU, FDA) / GDP / ISO 13485 (Medical Devices) Preparation and support on. Doctors can access cutting-edge devices for many difficult diseases to pursue our mission to save and improve lives. We have been in the field for 22 years and understand the importance of early market penetration. ISO 13485:2016, according to ISO’s site, specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory. I3CGlobal (IN) aspires to be India’s leading medical device consultants and service providers. ASB is committed to providing the highest quality innovative polymers that meet or exceed our customer’s requirements and expectations. Major Audit Examples: ISO 13485 audit and GMP 21 QSR 820 audit ISO 13485 audit.