ISO 13485:2016 - Towards a Global Quality System

(On-site or Virtual Private Group/Company Training)

Date: Your Choice

Location: On-site or Virtual

Who: Your entire company, department, project team, you select

Overview:
 
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. Changes to your Quality System must be done properly in order to comply and be certified by a registrar or notified body. The medical device world is becoming more global and by opening up a company's geographic reach, it can significantly increase its potential market. Many U.S. companies have realized that by modifying their U.S. 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. Areas such as Europe (EU), Canada, Australia, Asia, and Central & South America either accept ISO 13485 or a modified version of it (i.e. 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. Done properly, integrating compliance to all four requirements (U.S. 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. 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. 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..

What you will learn:

• Overview of the Global marketing benefits of complying with FDA, ISO 13485:2016, Canadian, and EU MDR/IVDR quality system requirements.
• Understand the differences between ISO 13485:2016, Canadian, U.S., and EU MDR/IVDR quality regulations.
• How to integrate ISO 13485:2016, US FDA, Canadian, and EU MDR/IVDR quality system regulations so that only one (1) quality system needs to be maintained.
• How to get certified and maintain compliance, including an overview of the Medical Device Single Audit Program (MDSAP).
• Simplicity is key.

Benefits of Attending:

• Greatly expanded market potential globally.
• Streamline compliance using only one quality system for compliance in U.S., EU, Canada.
• Preparation for marketing worldwide.
• Understanding how to get ISO 13485:2016 certified & maintain it.
• Simplifying the quality system process & compliance

Abbreviated Outline Draft:

• A. Overview of ISO 13485:2016
• B. Global medical device regulatory requirements review and global marketing benefits of compliance with ISO 13485:2016
• C. Overview of differences between ISO 13485:2016, FDA QSR/GMP, Canadian MDR, and EU MDR/IVDR
• D. Detailed look at the changes required in each element of a FDA complaint quality system to comply with ISO 13485:2016, Canadian MDR, and EU MDR/IVDR
• E. How to integrate ISO 13485:2016, Canada Requirements, and EU MDR/IVDR into FDA QS regulations and comply with only one quality system to maintain
• F. How to get certified including transition and the renewal processes
• G. Medical Device Single Audit Program (MDSAP) Overview
• H. Review and Summary

Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.

Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.

Request a training proposal for your company.