#ISO 13485 FDA HOW TO#

#ISO 13485 FDA HOW TO#

One of the goals of this course is to teach how to integrate ISO 13485:2016, Canadian MDRs, and EU MDR/IVDR requirements into an FDA QSR/GMP compliant quality system individuals not familiar with the FDA Quality System Regulation (21 CFR Part 820) or needing a refresher will find it beneficial to also consider the FDA QSR/GMP course. This course will be beneficial to Management, Quality, Regulatory, R&D, and Marketing personnel including Executive Management, vendors/suppliers/contract manufacturers to medical device manufacturers, and any other groups or departments impacted by the quality system that want to understand the impact of adding the additional compliance requirements to their daily responsibilities. FDA QS regulation, ISO 13485:2016, Canadian Medical Device Regulations (CMDR), and EU MDR/IVDR) into one quality system will require minimal impact to your company without needing to run & maintain 4 separate quality systems. Done properly, integrating compliance to all four requirements (U.S. nationalized to their own needs).in all that's a huge global market! Vendors, Suppliers and Contract Manufacturers also benefit with compliance to ISO 13485:2016 in terms of marketing their quality commitment and reduced customer audits. Areas such as Europe (EU), Canada, Australia, Asia, and Central & South America either accept ISO 13485 or a modified version of it (i.e. FDA compliant Quality System to comply with the requirements of ISO 13485, Canada, and European Union's Medical Device Regulation (EU MDR/IVDR, see CE Marking course) requirements they can gain substantial market potential. companies have realized that by modifying their U.S. The medical device world is becoming more global and by opening up a company's geographic reach, it can significantly increase its potential market. Changes to your Quality System must be done properly in order to comply and be certified by a registrar or notified body. This course will discuss the ISO 13485:2016, explain the differences between and what needs to be modified in a FDA (21 CFR Part 820) compliant Quality System in order to be compliant with the requirements of ISO 13485:2016 including the additional requirements for compliance in Canada and the European Union. Who: Your entire company, department, project team, you select

Iso 13485 fda